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Biomet, Inc.

469 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Various trauma and sports medicine instruments and implants. Appliance, fixation, nail/bla recall (Z-1825-2016)Biomet, Inc.2016-05-26
Various trauma and sports medicine instruments and implants. Spinal interlaminal fixation recall (Z-1826-2016)Biomet, Inc.2016-05-26
Various trauma and sports medicine instruments and implants. Orthopedic manual surgical in recall (Z-1827-2016)Biomet, Inc.2016-05-26
Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegrad recall (Z-1828-2016)Biomet, Inc.2016-05-26
PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral recall (Z-1814-2016)Biomet, Inc.2016-05-25
All instrumentation associated with the Prelude PF Resurfacing Knee System. recall (Z-1318-2016)Biomet, Inc.2016-04-04
Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total kne recall (Z-1265-2016)Biomet, Inc.2016-03-25
Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) Biomet C recall (Z-1093-2016)Biomet, Inc.2016-03-10
Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, sc recall (Z-1082-2016)Biomet, Inc.2016-03-08
HipLOC CHS Plate/Lag Screw Introducer recall (Z-0885-2016)Biomet, Inc.2016-02-25
Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13 recall (Z-0650-2016)Biomet, Inc.2016-01-13
A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of recall (Z-0450-2016)Biomet, Inc.2015-12-18
Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis. recall (Z-2483-2015)Biomet, Inc.2015-08-29
Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill guide. The Oxford Fixed recall (Z-2065-2015)Biomet, Inc.2015-07-14
A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument. recall (Z-2072-2015)Biomet, Inc.2015-07-14
A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw recall (Z-2058-2015)Biomet, Inc.2015-07-10
A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a mean recall (Z-2046-2015)Biomet, Inc.2015-07-08
Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for u recall (Z-1944-2015)Biomet, Inc.2015-07-01
Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for u recall (Z-1945-2015)Biomet, Inc.2015-07-01
Vanguard M Unicondylar Tibial Trial For use during knee joint replacement. recall (Z-1798-2015)Biomet, Inc.2015-06-15
Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Por recall (Z-1754-2015)Biomet, Inc.2015-06-11
Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standa recall (Z-1755-2015)Biomet, Inc.2015-06-11
MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 8 recall (Z-1756-2015)Biomet, Inc.2015-06-11
Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD COCR recall (Z-1757-2015)Biomet, Inc.2015-06-11
Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for u recall (Z-1741-2015)Biomet, Inc.2015-06-09
LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Provides the orthopa recall (Z-1446-2015)Biomet, Inc.2015-04-14
ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation D recall (Z-1363-2015)Biomet, Inc.2015-04-02
Ziploop Button Product Usage: The Ziploop Button is a non-resorbable system intended to ai recall (Z-1364-2015)Biomet, Inc.2015-04-02
Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Nu recall (Z-1208-2015)Biomet, Inc.2015-02-24
Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ring recall (Z-1122-2015)Biomet, Inc.2015-02-17
Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component. recall (Z-1123-2015)Biomet, Inc.2015-02-17
Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name: prosthesis, recall (Z-0822-2015)Biomet, Inc.2014-12-17
Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 14168 recall (Z-0823-2015)Biomet, Inc.2014-12-17
Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety of elbow joint recall (Z-0075-2015)Biomet, Inc.2014-10-16
Black Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to ai recall (Z-0056-2015)Biomet, Inc.2014-10-09
Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to ai recall (Z-0057-2015)Biomet, Inc.2014-10-09
Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments are utilized recall (Z-0058-2015)Biomet, Inc.2014-10-09
Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arth recall (Z-0021-2015)Biomet, Inc.2014-10-06
Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOS recall (Z-2242-2014)Biomet, Inc.2014-08-15
Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, recall (Z-2212-2014)Biomet, Inc.2014-08-13
DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLO recall (Z-1925-2014)Biomet, Inc.2014-06-26
G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthe recall (Z-1837-2014)Biomet, Inc.2014-06-19
G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosth recall (Z-1838-2014)Biomet, Inc.2014-06-19
EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Sur recall (Z-1801-2014)Biomet, Inc.2014-06-16
EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical I recall (Z-1802-2014)Biomet, Inc.2014-06-16
EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a n recall (Z-1803-2014)Biomet, Inc.2014-06-16
ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic i recall (Z-1615-2014)Biomet, Inc.2014-05-13
Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm, A unique and exclusive clinica recall (Z-1242-2014)Biomet, Inc.2014-03-20
Part 475625, Intramedullary Bone Saw, Cam Assembly Size 13 mm, The Biomet Intramedullary B recall (Z-1243-2014)Biomet, Inc.2014-03-20
Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Biomet Intramedullary B recall (Z-1244-2014)Biomet, Inc.2014-03-20
Locking Cortical Screw 3.5mmX38mm REF 8161-35-038 recall (Z-0716-2014)Biomet, Inc.2014-01-10
outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use Gamma recall (Z-0523-2014)Biomet, Inc.2013-12-17
G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000 recall (Z-0493-2014)Biomet, Inc.2013-12-13
REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Stee recall (Z-0381-2014)Biomet, Inc.2013-11-22
Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The Juggerknot recall (Z-0364-2014)Biomet, Inc.2013-11-19
REF 154200 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A3 ARCOM UHMWPE / recall (Z-1695-2013)Biomet, Inc.2013-07-11
REF 154201 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A4 ARCOM UHMWPE / recall (Z-1696-2013)Biomet, Inc.2013-07-11
REF 154202 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A5 ARCOM UHMWPE / recall (Z-1697-2013)Biomet, Inc.2013-07-11
REF 154203 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A6 ARCOM UHMWPE / recall (Z-1698-2013)Biomet, Inc.2013-07-11
REF 154204 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A7 ARCOM UHMWPE / recall (Z-1699-2013)Biomet, Inc.2013-07-11
REF 154207 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B3 ARCOM UHMWPE / recall (Z-1700-2013)Biomet, Inc.2013-07-11
REF 154208 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B4 ARCOM UHMWPE / recall (Z-1701-2013)Biomet, Inc.2013-07-11
REF 154209 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B5 ARCOM UHMWPE / recall (Z-1702-2013)Biomet, Inc.2013-07-11
REF 154210 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size 6ARCOM UHMWPE / C recall (Z-1703-2013)Biomet, Inc.2013-07-11
REF 154211 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B7 ARCOM UHMWPE / recall (Z-1704-2013)Biomet, Inc.2013-07-11
REF 154214 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C3 ARCOM UHMWPE / recall (Z-1705-2013)Biomet, Inc.2013-07-11
REF 154215 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C4 ARCOM UHMWPE / recall (Z-1706-2013)Biomet, Inc.2013-07-11
REF 154216 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C5 ARCOM UHMWPE / recall (Z-1707-2013)Biomet, Inc.2013-07-11
REF 154217 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C6 ARCOM UHMWPE / recall (Z-1708-2013)Biomet, Inc.2013-07-11
REF 154218 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C7 ARCOM UHMWPE / recall (Z-1709-2013)Biomet, Inc.2013-07-11
REF 154221 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D3 ARCOM UHMWPE / recall (Z-1710-2013)Biomet, Inc.2013-07-11
REF 154222 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D4 ARCOM UHMWPE / recall (Z-1711-2013)Biomet, Inc.2013-07-11
REF 154223 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D5 ARCOM UHMWPE / recall (Z-1712-2013)Biomet, Inc.2013-07-11
REF 154224 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D6 ARCOM UHMWPE / recall (Z-1713-2013)Biomet, Inc.2013-07-11
REF 154225Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D7 ARCOM UHMWPE / recall (Z-1714-2013)Biomet, Inc.2013-07-11
REF 154228 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E3 ARCOM UHMWPE / recall (Z-1715-2013)Biomet, Inc.2013-07-11
REF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E4 ARCOM UHMWPE / recall (Z-1716-2013)Biomet, Inc.2013-07-11
REF 154230 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E5 ARCOM UHMWPE / recall (Z-1717-2013)Biomet, Inc.2013-07-11
REF 154231Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E6 ARCOM UHMWPE / recall (Z-1718-2013)Biomet, Inc.2013-07-11
REF 154232 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E7 ARCOM UHMWPE / recall (Z-1719-2013)Biomet, Inc.2013-07-11
REF 154235Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F3 ARCOM UHMWPE / recall (Z-1720-2013)Biomet, Inc.2013-07-11
REF 154236 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F4 ARCOM UHMWPE / recall (Z-1721-2013)Biomet, Inc.2013-07-11
REF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F5 ARCOM UHMWPE / recall (Z-1722-2013)Biomet, Inc.2013-07-11
REF 154238 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F6 ARCOM UHMWPE / recall (Z-1723-2013)Biomet, Inc.2013-07-11
REF 154239 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F7 ARCOM UHMWPE / recall (Z-1724-2013)Biomet, Inc.2013-07-11
Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision t recall (Z-1548-2013)Biomet, Inc.2013-06-17
Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems. Product recall (Z-1547-2013)Biomet, Inc.2013-06-15
Active Articulation E1. Intended for use with either primary or revision hip arthroplasty. recall (Z-1465-2013)Biomet, Inc.2013-06-05
REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surg recall (Z-0925-2013)Biomet, Inc.2013-03-08
TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a vari recall (Z-0753-2013)Biomet, Inc.2013-01-30
PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, recall (Z-0660-2013)Biomet, Inc.2013-01-09
EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consist recall (Z-0527-2013)Biomet, Inc.2012-12-17
Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee jo recall (Z-0533-2013)Biomet, Inc.2012-12-17
Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product U recall (Z-0474-2013)Biomet, Inc.2012-12-05
OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL The OSS K recall (Z-0471-2013)Biomet, Inc.2012-12-04
OSS Reamer Sleeve REF132-472662 KNEE REAMER SLEEVE 13.0 thru 20.0 STAINLESS STEEL The OSS recall (Z-0472-2013)Biomet, Inc.2012-12-04
Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthope recall (Z-0442-2013)Biomet, Inc.2012-11-27
Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-he recall (Z-0415-2013)Biomet, Inc.2012-11-21
Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity Plating System recall (Z-2485-2012)Biomet, Inc.2012-09-28
Optilock T15 AO Driver (3.5mm). Intended Use: The OptiLock Upper Extremity Plating System recall (Z-2486-2012)Biomet, Inc.2012-09-28
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Every clearance here is in the API, with alerts when new ones post.