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Stryker Howmedica Osteonics Corp.

496 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Ster recall (Z-0060-2017)Stryker Howmedica Osteonics Corp.2016-10-07
Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 076 recall (Z-2789-2016)Stryker Howmedica Osteonics Corp.2016-09-13
Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide st recall (Z-2791-2016)Stryker Howmedica Osteonics Corp.2016-09-13
Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femora recall (Z-2792-2016)Stryker Howmedica Osteonics Corp.2016-09-13
Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument w recall (Z-2396-2016)Stryker Howmedica Osteonics Corp.2016-08-11
VariAx Compression Plating System recall (Z-1507-2016)Stryker Howmedica Osteonics Corp.2016-04-18
Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the temporary stabili recall (Z-0867-2016)Stryker Howmedica Osteonics Corp.2016-02-25
Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intended for the tempor recall (Z-0868-2016)Stryker Howmedica Osteonics Corp.2016-02-25
Stryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporary stabilization o recall (Z-0869-2016)Stryker Howmedica Osteonics Corp.2016-02-25
Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for the temporary sta recall (Z-0870-2016)Stryker Howmedica Osteonics Corp.2016-02-25
Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the temporary stabilization recall (Z-0871-2016)Stryker Howmedica Osteonics Corp.2016-02-25
Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended for the temporar recall (Z-0872-2016)Stryker Howmedica Osteonics Corp.2016-02-25
Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary stabilization of bo recall (Z-0873-2016)Stryker Howmedica Osteonics Corp.2016-02-25
Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm Product Usage: Intended for the temporary recall (Z-0874-2016)Stryker Howmedica Osteonics Corp.2016-02-25
Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary sta recall (Z-0875-2016)Stryker Howmedica Osteonics Corp.2016-02-25
Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended for the temporary s recall (Z-0876-2016)Stryker Howmedica Osteonics Corp.2016-02-25
Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended for the temporary recall (Z-0877-2016)Stryker Howmedica Osteonics Corp.2016-02-25
Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary s recall (Z-0878-2016)Stryker Howmedica Osteonics Corp.2016-02-25
Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended for the temporary recall (Z-0879-2016)Stryker Howmedica Osteonics Corp.2016-02-25
Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended for the temporar recall (Z-0880-2016)Stryker Howmedica Osteonics Corp.2016-02-25
Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm Product Usage: Intended for the temporary s recall (Z-0881-2016)Stryker Howmedica Osteonics Corp.2016-02-25
Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended for the temporary recall (Z-0882-2016)Stryker Howmedica Osteonics Corp.2016-02-25
Stryker, T2 K-Wire, 3.2x400mm, Recon Product Usage: Intended for the temporary stabilizati recall (Z-0883-2016)Stryker Howmedica Osteonics Corp.2016-02-25
Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for the temporary stabi recall (Z-0884-2016)Stryker Howmedica Osteonics Corp.2016-02-25
Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is recall (Z-0362-2016)Stryker Howmedica Osteonics Corp.2015-12-02
Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hi recall (Z-0281-2016)Stryker Howmedica Osteonics Corp.2015-11-17
Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component. recall (Z-0261-2016)Stryker Howmedica Osteonics Corp.2015-11-10
Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723 recall (Z-0249-2016)Stryker Howmedica Osteonics Corp.2015-11-09
Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component recall (Z-2810-2015)Stryker Howmedica Osteonics Corp.2015-09-23
rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proxima recall (Z-2426-2015)Stryker Howmedica Osteonics Corp.2015-08-20
uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of recall (Z-2427-2015)Stryker Howmedica Osteonics Corp.2015-08-20
Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the recall (Z-2428-2015)Stryker Howmedica Osteonics Corp.2015-08-20
Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for recall (Z-2429-2015)Stryker Howmedica Osteonics Corp.2015-08-20
Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for replaceme recall (Z-2430-2015)Stryker Howmedica Osteonics Corp.2015-08-20
Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 (component of recall (Z-2389-2015)Stryker Howmedica Osteonics Corp.2015-08-14
Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product recall (Z-2360-2015)Stryker Howmedica Osteonics Corp.2015-08-10
ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S- recall (Z-2363-2015)Stryker Howmedica Osteonics Corp.2015-08-10
Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Cor recall (Z-1633-2015)Stryker Howmedica Osteonics Corp.2015-05-19
Stryker Orthopaedics Scorpio femoral component. Howmedica Osteonics Corp., A subsidiary of recall (Z-1634-2015)Stryker Howmedica Osteonics Corp.2015-05-19
Stryker Orthopaedics Triathlon femoral component. Howmedica Osteonics Corp., A subsidiary recall (Z-1635-2015)Stryker Howmedica Osteonics Corp.2015-05-19
Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extenders are modular recall (Z-1614-2015)Stryker Howmedica Osteonics Corp.2015-05-14
Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal Capture Asse recall (Z-1283-2015)Stryker Howmedica Osteonics Corp.2015-03-16
LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to b recall (Z-1241-2015)Stryker Howmedica Osteonics Corp.2015-03-03
Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cement recall (Z-1043-2015)Stryker Howmedica Osteonics Corp.2015-02-03
Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08 recall (Z-0065-2015)Stryker Howmedica Osteonics Corp.2014-10-14
Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: Th recall (Z-1978-2014)Stryker Howmedica Osteonics Corp.2014-07-02
Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 recall (Z-1317-2014)Stryker Howmedica Osteonics Corp.2014-04-02
Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Hos recall (Z-0975-2014)Stryker Howmedica Osteonics Corp.2014-02-12
Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a packa recall (Z-0964-2014)Stryker Howmedica Osteonics Corp.2014-02-10
Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sc recall (Z-0849-2014)Stryker Howmedica Osteonics Corp.2014-01-28
Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery. recall (Z-0582-2014)Stryker Howmedica Osteonics Corp.2013-12-27
Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery. recall (Z-0583-2014)Stryker Howmedica Osteonics Corp.2013-12-27
Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker France Both t recall (Z-0483-2014)Stryker Howmedica Osteonics Corp.2013-12-11
1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, S recall (Z-0467-2014)Stryker Howmedica Osteonics Corp.2013-12-07
Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) ref recall (Z-2130-2013)Stryker Howmedica Osteonics Corp.2013-08-29
Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulate recall (Z-2099-2013)Stryker Howmedica Osteonics Corp.2013-08-27
GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp recall (Z-1846-2013)Stryker Howmedica Osteonics Corp.2013-07-31
Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package How recall (Z-1370-2013)Stryker Howmedica Osteonics Corp.2013-05-23
Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Locking Plate System recall (Z-1210-2013)Stryker Howmedica Osteonics Corp.2013-05-01
ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be recall (Z-1052-2013)Stryker Howmedica Osteonics Corp.2013-04-12
Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteoni recall (Z-1061-2013)Stryker Howmedica Osteonics Corp.2013-04-05
Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Siz recall (Z-0964-2013)Stryker Howmedica Osteonics Corp.2013-03-18
Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-1 recall (Z-0919-2013)Stryker Howmedica Osteonics Corp.2013-03-08
Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003. recall (Z-0695-2013)Stryker Howmedica Osteonics Corp.2013-01-17
Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degr recall (Z-0656-2013)Stryker Howmedica Osteonics Corp.2013-01-08
Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073 recall (Z-0610-2013)Stryker Howmedica Osteonics Corp.2012-12-22
Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS REF 6543-1-600;N recall (Z-0469-2013)Stryker Howmedica Osteonics Corp.2012-12-04
Stryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS REF 6543-2-600;N recall (Z-0470-2013)Stryker Howmedica Osteonics Corp.2012-12-04
Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 The 6.5mm Cancellous recall (Z-0387-2013)Stryker Howmedica Osteonics Corp.2012-11-19
Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous recall (Z-0388-2013)Stryker Howmedica Osteonics Corp.2012-11-19
Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extension Component Pr recall (Z-0286-2013)Stryker Howmedica Osteonics Corp.2012-11-13
Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed i recall (Z-0266-2013)Stryker Howmedica Osteonics Corp.2012-11-08
Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill In recall (Z-2487-2012)Stryker Howmedica Osteonics Corp.2012-09-28
Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Osteonics Corp., 59 recall (Z-2084-2012)Stryker Howmedica Osteonics Corp.2012-07-26
ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland recall (Z-2089-2012)Stryker Howmedica Osteonics Corp.2012-07-26
Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill Cou recall (Z-2090-2012)Stryker Howmedica Osteonics Corp.2012-07-26
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntsc recall (Z-2016-2012)Stryker Howmedica Osteonics Corp.2012-07-16
Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 62 recall (Z-1982-2012)Stryker Howmedica Osteonics Corp.2012-07-10
Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corp recall (Z-1816-2012)Stryker Howmedica Osteonics Corp.2012-06-15
Restoration HA Reduced Neck 255 mm Long Stem Manufactured by Stryker Howmedica Osteonics C recall (Z-1677-2012)Stryker Howmedica Osteonics Corp.2012-05-29
Cutting Edge Acetabular Spherical Reamer 44 M, Stryker Howmedica Osteonics Howmedica Osteo recall (Z-1618-2012)Stryker Howmedica Osteonics Corp.2012-05-17
Tibial Alignment Handle Triathlon Instruments CAT #: 6541-2-807 Nav Tibial Alignment Handl recall (Z-1619-2012)Stryker Howmedica Osteonics Corp.2012-05-17
Osteonics Shoulder Glenoid Spanner Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, N recall (Z-1276-2012)Stryker Howmedica Osteonics Corp.2012-03-22
Duration packaging distributed by Stryker Orthopaedics, Limerick, Ireland Stryker Ireland recall (Z-0931-2012)Stryker Howmedica Osteonics Corp.2012-01-30
Brand Name: Custom Straight Accolade Common Name: Handle Classification Name: Orthopedics recall (Z-0804-2012)Stryker Howmedica Osteonics Corp.2012-01-18
Eius Unicompartmental Knee System Stryker Howmedica Osteonics Corp. Howmedica Internationa recall (Z-0606-2012)Stryker Howmedica Osteonics Corp.2012-01-11
Stryker Modular Dual Mobility (MDM) Liner and X3 Acetabular Insert; Howmedica Osteonics Co recall (Z-0192-2012)Stryker Howmedica Osteonics Corp.2011-11-16
Stryker Restoration ADM System X3 Acetabular Insert Howmedica Osteonics Corp., 325 Corpora recall (Z-0193-2012)Stryker Howmedica Osteonics Corp.2011-11-16
Stryker Restoration ADM System Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ recall (Z-0194-2012)Stryker Howmedica Osteonics Corp.2011-11-16
Total Hip Joint Replacement Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #3 Accolade TMZ recall (Z-0075-2012)Stryker Howmedica Osteonics Corp.2011-10-20
Accolade TMZF Plus Hip Stem: Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5 Catalog #602 recall (Z-2557-2011)Stryker Howmedica Osteonics Corp.2011-06-13
Xcelerate Specialty Patella Milling System Per File K2399; Catalog Number I-K2399PR00, I-K recall (Z-1862-2011)Stryker Howmedica Osteonics Corp.2011-03-31
Triathlon PKR Peg Drill, Catalog Number: 5650-4-512 (Size 1-2 Peg Drill); Catalog Number: recall (Z-1835-2011)Stryker Howmedica Osteonics Corp.2011-03-28
SCORPIO CR TIBIAL TRIAL, non sterile, made in the USA Howmedica Osteonics Corp., 325 Corpo recall (Z-1681-2011)Stryker Howmedica Osteonics Corp.2011-03-16
SCORPIO PS TIBIAL TRIAL, non sterile, made in the USA Howmedica Osteonics Corp., 325 Corpo recall (Z-1682-2011)Stryker Howmedica Osteonics Corp.2011-03-16
SCORPIO-FLEX PS TIBIAL TRIAL, non sterile, made in the USA Howmedica Osteonics Corp., 325 recall (Z-1683-2011)Stryker Howmedica Osteonics Corp.2011-03-16
SCORPIO-FLEX CR TIBIAL TRIAL, non sterile, made in the USA Howmedica Osteonics Corp., 325 recall (Z-1684-2011)Stryker Howmedica Osteonics Corp.2011-03-16
S T-Bone Plate; M T-Compression Plate; Manufactured and Distributed by Stryker Lebinger Gm recall (Z-1334-2011)Stryker Howmedica Osteonics Corp.2011-02-16
Triathlon Femoral Distal Fixation Peg; Catalog Number 5575-X-00; Manufactured by Stryker H recall (Z-1095-2011)Stryker Howmedica Osteonics Corp.2011-02-11
Omnifit M/S PSL Porous Coated Acetabular Shell 40MM; Stryker Orthopaedics, Uses in primary recall (Z-1046-2011)Stryker Howmedica Osteonics Corp.2011-02-07
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