PlainRecalls

Biomet, Inc.

174 recalls on record · Latest: Oct 1, 2025

FDA Devices Moderate Jun 1, 2016

PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.

FDA Devices Moderate Jun 1, 2016

Various trauma and sports medicine instruments and implants. Spinal interlaminal fixation orthosis.

FDA Devices Moderate Jun 1, 2016

Various trauma and sports medicine instruments and implants. Screw, fixation, bone.

FDA Devices Moderate Jun 1, 2016

Various trauma and sports medicine instruments and implants. Arthroscope.

FDA Devices Moderate Jun 1, 2016

Various trauma and sports medicine instruments and implants. Orthopedic manual surgical instrument.

FDA Devices Moderate Jun 1, 2016

Various trauma and sports medicine instruments and implants. cannula, surgical, general & plastic surgery and accessories

FDA Devices Moderate Jun 1, 2016

Various trauma and sports medicine instruments and implants. Reamer.

FDA Devices Moderate Jun 1, 2016

Various trauma and sports medicine instruments and implants. Plate, fixation, bone.

FDA Devices Moderate Jun 1, 2016

Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegradable, soft tissue.

FDA Devices Moderate Jun 1, 2016

Various trauma and sports medicine instruments and implants. Appliance, fixation, nail/blade/plate combination, multiple component.

FDA Devices Moderate Apr 13, 2016

All instrumentation associated with the Prelude PF Resurfacing Knee System.

FDA Devices Moderate Mar 16, 2016

Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation The Cross …

FDA Devices Moderate Mar 2, 2016

HipLOC CHS Plate/Lag Screw Introducer

FDA Devices Moderate Jan 20, 2016

Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm

FDA Devices Moderate Dec 30, 2015

Black Mamba Suture Passer

FDA Devices Moderate Dec 30, 2015

Green Mamba Suture Passer

FDA Devices Moderate Sep 9, 2015

Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis.

FDA Devices Moderate Jul 22, 2015

A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw

FDA Devices Moderate Jul 15, 2015

A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management…

FDA Devices Moderate Jul 8, 2015

Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures

FDA Devices Moderate Jul 8, 2015

Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment procedures.

FDA Devices Moderate Jun 24, 2015

Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.

FDA Devices Moderate Jun 17, 2015

Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to treatment b…

FDA Devices Low Jun 17, 2015

Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement compon…

FDA Devices Low Jun 17, 2015

Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD COCR -3 MM NECK; 32MM MOD HEAD COCR STD NECK ; 32MM MOD HEAD CO…

FDA Devices Low Jun 17, 2015

Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size…

FDA Devices Low Jun 17, 2015

MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components i…

FDA Devices Moderate Apr 22, 2015

LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Provides the orthopaedic surgeon a means of bone fixation and helps general…

FDA Devices Moderate Mar 4, 2015

Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400

FDA Devices Moderate Feb 25, 2015

Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)

FDA Devices Moderate Feb 25, 2015

Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component.

FDA Devices Moderate Dec 24, 2014

Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemented Device Co…

FDA Devices Moderate Dec 24, 2014

Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 141680, 180920 The Biomet's Sirius Femoral Hip Stem is a do…

FDA Devices Moderate Oct 22, 2014

Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety of elbow joint replacement prostheses intended for primary and revisi…

FDA Devices Moderate Oct 15, 2014

Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needl…

FDA Devices Moderate Aug 27, 2014

Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET ORTHOPEDICS 56 EAST BE…

FDA Devices Moderate Jul 2, 2014

DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement prostheses …

FDA Devices Moderate Jun 25, 2014

EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical Instrument Sterile, single use arthroscopic instrument utili…

FDA Devices Moderate Jun 25, 2014

EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. …

FDA Devices Moderate Jun 25, 2014

EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Surgical Instrument, Sterile, single use arthroscopic instrum…

FDA Devices Moderate Mar 26, 2014

Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrume…

FDA Devices Moderate Jan 1, 2014

G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000

FDA Devices Moderate Dec 4, 2013

REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device, Single Use Only. Designed to relea…

FDA Devices Moderate Jul 17, 2013

REF 154216 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Ste…

FDA Devices Moderate Jul 17, 2013

REF 154211 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Ste…

FDA Devices Moderate Jul 17, 2013

REF 154225Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Ster…

FDA Devices Moderate Jul 17, 2013

REF 154215 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Ste…

FDA Devices Moderate Jul 17, 2013

REF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Ste…

FDA Devices Moderate Jul 17, 2013

REF 154239 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Ste…

FDA Devices Moderate Jul 17, 2013

REF 154235Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Ster…