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Biomet, Inc.

469 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
STA-Flex SUBTALAR SCREW, 12 mm x 18 mm, REF 982366, Sterile, Biomet Sports Medicine, 56 Ea recall (Z-1617-2011)Biomet, Inc.2011-03-09
STA-Flex SUBTALAR SCREW, 13 mm x 19 mm, REF 982367, Sterile, Biomet Sports Medicine, 56 Ea recall (Z-1618-2011)Biomet, Inc.2011-03-09
Biomet INNERVUE DISPOSABLE SCOPE KIT 1.2MM, PRODUCT NUMBER 922140, STERILE recall (Z-1588-2011)Biomet, Inc.2011-03-07
Biomet INNERVUE DISPOSABLE SCOPE KIT 1.2MM WITH CANNULA SET, PRODUCT NUMBER 922141, STERIL recall (Z-1589-2011)Biomet, Inc.2011-03-07
ARCOS Modular Revision System Torque Limiting T-Handle 55 inch- pounds, REF 31-301850, Bio recall (Z-1594-2011)Biomet, Inc.2011-03-07
Cylindrical Bullet Nose Reamer 7.0 mm x 250 mm, REF 475802, Biomet Orthopedics 66 East Bel recall (Z-1527-2011)Biomet, Inc.2011-03-04
Cylindrical Bullet Nose Reamer 7.5 mm x 250 mm, REF 475803, Biomet Orthopedics 66 East Bel recall (Z-1528-2011)Biomet, Inc.2011-03-04
Cylindrical Bullet Nose Reamer 8.0 mm x 250 mm, REF 475804, Biomet Orthopedics 66 East Bel recall (Z-1529-2011)Biomet, Inc.2011-03-04
Cylindrical Bullet Nose Reamer 8.5 mm x 250 mm, REF 475805, Biomet Orthopedics 66 East Bel recall (Z-1530-2011)Biomet, Inc.2011-03-04
Cylindrical Bullet Nose Reamer 9.5 mm x 250 mm, REF 475807, Biomet Orthopedics 66 East Bel recall (Z-1531-2011)Biomet, Inc.2011-03-04
Cylindrical Bullet Nose Reamer 10.5 mm x 250 mm, REF 475809, Biomet Orthopedics 66 East Be recall (Z-1532-2011)Biomet, Inc.2011-03-04
Cylindrical Bullet Nose Reamer 11.0 mm x 250 mm, REF 475810, Biomet Orthopedics 66 East Be recall (Z-1533-2011)Biomet, Inc.2011-03-04
Cylindrical Bullet Nose Reamer 11.5 mm x 250 mm, REF 475811, Biomet Orthopedics 66 East Be recall (Z-1534-2011)Biomet, Inc.2011-03-04
Cylindrical Bullet Nose Reamer 12.0 mm x 250 mm, REF 475812, Biomet Orthopedics 66 East Be recall (Z-1535-2011)Biomet, Inc.2011-03-04
Cylindrical Bullet Nose Reamer 12.5 mm x 250 mm, REF 475813, Biomet Orthopedics 66 East Be recall (Z-1536-2011)Biomet, Inc.2011-03-04
Cylindrical Bullet Nose Reamer 13.0 mm x 250 mm, REF 475814, Biomet Orthopedics 66 East Be recall (Z-1537-2011)Biomet, Inc.2011-03-04
Cylindrical Bullet Nose Reamer 13.5 mm x 250 mm, REF 475815, Biomet Orthopedics 66 East Be recall (Z-1538-2011)Biomet, Inc.2011-03-04
Cylindrical Bullet Nose Reamer 14.0 mm x 250 mm, REF 475816, Biomet Orthopedics 66 East Be recall (Z-1539-2011)Biomet, Inc.2011-03-04
Cylindrical Bullet Nose Reamer 14.5 mm x 250 mm, REF 475817, Biomet Orthopedics 66 East Be recall (Z-1540-2011)Biomet, Inc.2011-03-04
Cylindrical Bullet Nose Reamer 15.0 mm x 250 mm, REF 475818, Biomet Orthopedics 66 East Be recall (Z-1541-2011)Biomet, Inc.2011-03-04
Cylindrical Bullet Nose Reamer 15.5 mm x 250 mm, REF 475819, Biomet Orthopedics 66 East Be recall (Z-1542-2011)Biomet, Inc.2011-03-04
Cylindrical Bullet Nose Reamer 17.5 mm x 250 mm, REF 475823, Biomet Orthopedics 66 East Be recall (Z-1543-2011)Biomet, Inc.2011-03-04
Cylindrical Bullet Nose Reamer 18.0 mm x 250 mm, REF 475824, Biomet Orthopedics 66 East Be recall (Z-1544-2011)Biomet, Inc.2011-03-04
Cylindrical Bullet Nose Reamer 19.0 mm x 250 mm, REF 475826, Biomet Orthopedics 66 East Be recall (Z-1545-2011)Biomet, Inc.2011-03-04
Cylindrical Bullet Nose Reamer 19.5 mm x 250 mm, REF 475827, Biomet Orthopedics 66 East Be recall (Z-1546-2011)Biomet, Inc.2011-03-04
Cylindrical Reamer Bullet Nose Straight Flutes 20.5 mm x 250 mm, REF 475829, Biomet Orthop recall (Z-1547-2011)Biomet, Inc.2011-03-04
Vanguard Knee Instruments offset reamer bushing - angled, REF 32-488519, Biomet Bridgend, recall (Z-0829-2011)Biomet, Inc.2010-12-28
Comprehensive Reverse Shoulder Humeral Tray with Locking Ring, 49 mm standard, sterile, RE recall (Z-0712-2011)Biomet, Inc.2010-12-16
Custom Comprehensive Shoulder Bio-Modular Base, 44 mm Humeral Tray standard, sterile, REF recall (Z-0713-2011)Biomet, Inc.2010-12-16
Closed knot pusher REF 902813, Biomet Sports Medicine, Warsaw, IN. The device is intended recall (Z-0059-2011)Biomet, Inc.2010-10-14
7 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900727, Sterile, BIOMET Sports recall (Z-2597-2010)Biomet, Inc.2010-09-28
8 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900728, Sterile, BIOMET Sports recall (Z-2598-2010)Biomet, Inc.2010-09-28
9 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900729, Sterile, BIOMET Sports recall (Z-2599-2010)Biomet, Inc.2010-09-28
10 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900730, Sterile, BIOMET Sport recall (Z-2600-2010)Biomet, Inc.2010-09-28
7 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900737, Sterile, BIOMET Spo recall (Z-2601-2010)Biomet, Inc.2010-09-28
8 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900738, Sterile, BIOMET Spo recall (Z-2602-2010)Biomet, Inc.2010-09-28
9 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900739, Sterile, BIOMET Spo recall (Z-2603-2010)Biomet, Inc.2010-09-28
10 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900740, Sterile, BIOMET Sp recall (Z-2604-2010)Biomet, Inc.2010-09-28
8 MM DISPOSABLE CORING TREPHINE STAGGERED TEETH WITH PROTECTION SLEEVE, REF 900788, Steril recall (Z-2605-2010)Biomet, Inc.2010-09-28
Modular Microplasty Cup inserter 3/8" thread , REF 31-400600 recall (Z-2504-2010)Biomet, Inc.2010-09-25
Modular Microplasty Cup impactor 1/4" - 28 thread insert , REF 31-400605 recall (Z-2505-2010)Biomet, Inc.2010-09-25
SpeedPass Disposable Suture Lariat with Nitinol Wire 45 Degree Up, QTY. 1, Biomet Sports M recall (Z-2228-2010)Biomet, Inc.2010-08-16
SpeedPass Disposable Suture Lariat with Nitinol Wire 25 Degree Left, QTY. 1, Biomet Sports recall (Z-2229-2010)Biomet, Inc.2010-08-16
SpeedPass Disposable Suture Lariat with Nitinol Wire 25 Degree Right, QTY. 1, Biomet Sport recall (Z-2230-2010)Biomet, Inc.2010-08-16
Suture Lariat 30 Degree Up, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Par recall (Z-2231-2010)Biomet, Inc.2010-08-16
Suture Lariat 45 Degree Dog Leg Up, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Ster recall (Z-2232-2010)Biomet, Inc.2010-08-16
Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, REF 183022, Knee prosthesis com recall (Z-2204-2010)Biomet, Inc.2010-08-10
Artificial ligament fixation device # 7PE ZIPLOOP Extended Toggle, Sterile, REF 904755, Bi recall (Z-1952-2010)Biomet, Inc.2010-07-01
Toggleloc Artificial ligament fixation device ZIPLOOP Technology Implant Kit, Sterile, REF recall (Z-1953-2010)Biomet, Inc.2010-07-01
Mallory Head Calcar Provisional, 34 mm replacement stem, 11 mm x 220 mm left, Sterile, REF recall (Z-1665-2010)Biomet, Inc.2010-05-26
Mallory Head Calcar Provisional, 45 mm replacement stem, 13.0 x 220 mm left, Sterile, REF recall (Z-1666-2010)Biomet, Inc.2010-05-26
Mallory Head Calcar Femoral, 34 mm resection/porous coated, 9mm x 170 mm stem, Sterile, RE recall (Z-1667-2010)Biomet, Inc.2010-05-26
Mallory Head Calcar Femoral, 34 mm resection/porous coated, 13.0 x 170 mm,, Sterile, REF 1 recall (Z-1668-2010)Biomet, Inc.2010-05-26
Mallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x 170 mm stem, Sterile recall (Z-1669-2010)Biomet, Inc.2010-05-26
Mallory Head Calcar Provisional, 55 mm resection/porous coated, 17.0 mm x 260 mm left, Ste recall (Z-1670-2010)Biomet, Inc.2010-05-26
Mallory Head Calcar Femoral, 34 mm resection/porous coated, 9.0 mm x 220 mm right stem, St recall (Z-1671-2010)Biomet, Inc.2010-05-26
Mallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x 220 mm right stem, S recall (Z-1672-2010)Biomet, Inc.2010-05-26
Mallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x 220 mm left stem, St recall (Z-1673-2010)Biomet, Inc.2010-05-26
Mallory Head Calcar Femoral, 55 mm resection/porous coated, 15.0 mm x 220 mm right stem, S recall (Z-1674-2010)Biomet, Inc.2010-05-26
Mallory Head Calcar Femoral 55 mm resection/porous coated 15.0 mm x 220 mm left stem, Ster recall (Z-1675-2010)Biomet, Inc.2010-05-26
17 mm Mallory Head Calcar 45 mm repl. fmrl. /100% porous 18.5 mm minimum ream dia x 260 mm recall (Z-1676-2010)Biomet, Inc.2010-05-26
17 mm Mallory Head Calcar 55 mm repl. femoral/100% porous 18.5 mm minimum ream dia. x 220 recall (Z-1677-2010)Biomet, Inc.2010-05-26
19 mm Mallory Head Calcar 45 mm repl. femoral/100% porous 20.5 mm minimum ream dia. x 260 recall (Z-1678-2010)Biomet, Inc.2010-05-26
19 mm Mallory Head Calcar 55 mm repl. femoral/100% porous 20.5 mm minimum ream dia. x 260 recall (Z-1679-2010)Biomet, Inc.2010-05-26
Biomet bone mulch screw, 10.5mm x 20 mm, TI-6AL-4V alloy, sterile, Biomet Sports Medicine, recall (Z-0779-2010)Biomet, Inc.2010-02-02
Biomet Vanguard Lock-On Femoral Impactor, Biomet Orthopedics. Warsaw. IN; REF 32-486206. N recall (Z-0646-2010)Biomet, Inc.2010-01-15
Biomet 2.9 Micromax L-15 suture anchor, flexible long shaft, #2 blue/white maxbraid, PLLA/ recall (Z-0611-2010)Biomet, Inc.2010-01-13
Toggleloc System, Biomet Ziptight Ankle Syndesmosis Fixation System - Titanium with Ziploo recall (Z-0559-2010)Biomet, Inc.2009-12-22
Toggleloc System, Biomet Ziptight Ankle Syndesmosis Fixation System - SS with Ziploop Tech recall (Z-0560-2010)Biomet, Inc.2009-12-22
Biomet K-Wire/Trocar Point, both ends/Dia. 045, length: 9 in., certified stainless steel, recall (Z-0367-2010)Biomet, Inc.2009-11-19
Biomet 5.5 mm peek Allthread PEEK Knotless Anchor, knotless, sterile, Biomet sports Medici recall (Z-0191-2010)Biomet, Inc.2009-11-12
Biomet 8.0MM cannulated reamer for the Aimer system, Biomet Sports Medicine, Ontario, CA; recall (Z-2042-2009)Biomet, Inc.2009-09-08
Biomet Biolox-Delta Modular Ceramic Head, 28 mm head diameter, plus 5 neck, type 1, taper, recall (Z-1613-2009)Biomet, Inc.2009-07-14
Biomet Modular TTPA Ceramic Head, 28 mm head diameter plus 5 mm neck, sterile, Biomet Orth recall (Z-1614-2009)Biomet, Inc.2009-07-14
Biomet Optivac Total Hip Kit, Maximum Capacity Cartridge, 1 kit, sterile, latex free, Biom recall (Z-1480-2009)Biomet, Inc.2009-06-30
Biomet OSS FINN Proximal Femoral Trial 7 cm resection/right, stainless steel, Biomet Ortho recall (Z-1526-2009)Biomet, Inc.2009-06-29
Biomet OSS FINN Proximal Femoral Trial 7 cm resection/left, stainless steel, Biomet Orthop recall (Z-1527-2009)Biomet, Inc.2009-06-29
Biomet OSS Letson Proximal Femoral Trial 7 cm resection/right, stainless steel, Biomet Ort recall (Z-1528-2009)Biomet, Inc.2009-06-29
Biomet OSS Letson Proximal Femoral Trial 7 cm resection/left, stainless steel, Biomet Orth recall (Z-1529-2009)Biomet, Inc.2009-06-29
Biomet OSS Elliptical Proximal Femoral Trial 7 cm, right provisional, stainless steel, Bio recall (Z-1530-2009)Biomet, Inc.2009-06-29
Biomet OSS Elliptical Proximal Femoral Trial 7 cm left provisional, stainless steel, Biome recall (Z-1531-2009)Biomet, Inc.2009-06-29
Biomet Dual Offset Broach Handle, Clamping Style, Left, REF 31-555403. For use in primary recall (Z-1352-2009)Biomet, Inc.2009-06-01
Biomet Dual Offset Broach Handle, Clamping Style, Right, REF 31-555404. For use in primary recall (Z-1353-2009)Biomet, Inc.2009-06-01
Biomet Marrowstim Concentration Kit w/single Disposable Separator, Bone Marrow Needle, and recall (Z-1207-2009)Biomet, Inc.2009-04-17
Biomet Offset Tibial Tray Adaptor, 5.0 MM, sterile, Biomet Orthopedics, Inc., Warsaw, IN, recall (Z-1061-2009)Biomet, Inc.2009-04-07
Biomet Oxford Unicompartmental Knee, Phase 3, Right Medical Tibial Tray, Standard Size B, recall (Z-0962-2009)Biomet, Inc.2009-02-03
Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 55 mm, Biomet Orthoped recall (Z-0873-2009)Biomet, Inc.2009-01-13
Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 57.5 mm, Biomet Orthop recall (Z-0874-2009)Biomet, Inc.2009-01-13
Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 60 mm, Biomet Orthoped recall (Z-0875-2009)Biomet, Inc.2009-01-13
Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 62.5 mm, Biomet Orthop recall (Z-0876-2009)Biomet, Inc.2009-01-13
Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 65 mm, Biomet Orthoped recall (Z-0877-2009)Biomet, Inc.2009-01-13
Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 67.5 mm, Biomet Orthop recall (Z-0878-2009)Biomet, Inc.2009-01-13
Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 70 mm, Biomet Orthoped recall (Z-0879-2009)Biomet, Inc.2009-01-13
Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 75 mm, Biomet Orthoped recall (Z-0880-2009)Biomet, Inc.2009-01-13
Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 80 mm, Biomet Orthoped recall (Z-0881-2009)Biomet, Inc.2009-01-13
Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 72.5 mm, Biomet Orthop recall (Z-0882-2009)Biomet, Inc.2009-01-13
Compress Instrument Anchor Plug Holder, stainless steel, Biomet Orthopedics, Inc., Warsaw, recall (Z-0517-2009)Biomet, Inc.2009-01-07
Compress Instrument 13mm Anchor Plug Holder, stainless steel/TiAIN, Biomet Orthopedics, In recall (Z-0518-2009)Biomet, Inc.2009-01-07
Compress/Finn Instrument Set Compress Anchor Plug Assembly, stainless steel, Biomet Orthop recall (Z-0519-2009)Biomet, Inc.2009-01-07
Compress Short Instruments Anchor Plug Holder, 12mm, stainless steel, non-sterile, Biomet recall (Z-0520-2009)Biomet, Inc.2009-01-07
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Every clearance here is in the API, with alerts when new ones post.