Manufacturer

Biomet, Inc.

255 recalls in our database name Biomet, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 255
Critical: 0
Severe: 9
Most recent: 2026-08-12

Of the 255 recalls from Biomet, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (4%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

176–200 of 255

LowFDA (Devices)·Z-1754-2015·2015-06-17
Biomet Recalls Hip Components Due to Incorrect GTIN Labeling Codes
Biomet is recalling specific hip joint replacement components because the device labeling contains incorrect Global Trade Identification Number (GTIN) codes.
Product
Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- Metric Femoral Components. Hip joint replacement components include: femoral stems, femoral heads, acetabular sh
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1757-2015·2015-06-17
Biomet Recalls Hip Joint Components Due to Incorrect GTIN Labeling
Biomet is recalling 1,315 hip joint replacement components because the device labeling contains incorrect Global Trade Identification Number (GTIN) codes.
Product
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 COCR +3MM NECK; 32MM COCR MOD HD +6MM NO SKIRT Hip joint replacement components include: femoral stems, femoral heads, acetabular
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1756-2015·2015-06-17
Biomet Knee Joint Replacement Components Recalled for Incorrect GTIN Codes
Biomet is recalling MCK Maximum Congruent Knee System components because the device labeling contains incorrect Global Trade Identification Number (GTIN) codes.
Product
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 include femoral, tibial, and patellar components.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1755-2015·2015-06-17
Biomet Shoulder Joint Replacement Components Recalled for Incorrect GTIN Codes
Biomet, Inc. is recalling specific shoulder joint replacement components because the device labeling contains incorrect Global Trade Identification Number (GTIN) codes.
Product
Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1446-2015·2015-04-22
Biomet Recalls Low Profile Non-Locking Screws Due to Anodizing Error
Biomet is recalling 45 Low Profile Non-Locking Screws because they were anodized green instead of the required gold color.
Product
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 generally in the management of fractures and reconstructive surgeries.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1364-2015·2015-04-08
Biomet Recalls Ziploop Button and ToggleLocs Due to Packaging Seal Issues
Biomet, Inc. is recalling 50 units of Ziploop Buttons and ToggleLocs manufactured in 2014 because sterile packaging was not properly sealed.
Product
Ziploop Button Product Usage: The Ziploop Button is a non-resorbable system intended to aid in ACL reconstructive procedure due to injury or degenerative disease
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1363-2015·2015-04-08
Biomet Recalls ToggleLoc and Ziploop Fixation Devices Due to Packaging Defects
Biomet is recalling ToggleLoc and Ziploop devices manufactured in 2014 because sterile packaging was not sealed, potentially compromising sterility.
Product
ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation Device #7 PE Ziploop Extended Toggleloc Product Usage: The Toggleloc System is a non-resorbable system intended to aid in arthroscopic and orthopedic reconstructive procedures requiring s
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1208-2015·2015-03-04
Biomet Shoulder Implant Recall Due to Missing Taper Adaptor
Biomet is recalling specific shoulder implant baseplates because a taper adaptor is missing from the packaging, which may delay surgery.
Product
Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-1123-2015·2015-02-25
Biomet Recalls Acetabular Shell Components Due to Packaging Mix-Up
Biomet is recalling specific acetabular shell components for hip prostheses due to a packaging mix-up between two different product lots.
Product
Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1122-2015·2015-02-25
Biomet Recalls Specific Lot of Mallory Head Acetabular Shell Components
Biomet is recalling 17 units of the Mallory Head 4 Finned Acetabular Shell 50 mm (Lot 364600) due to a packaging mix-up with a different shell size.
Product
Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0823-2015·2014-12-24
Biomet Sirius Cemented Hip Stem Recall Due to Packaging Mix-up
Biomet is recalling eight Sirius Polish Cemented Hip Stems because parts were mixed up prior to packaging and shipment.
Product
Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 141680, 180920 The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem, designed for either primary or revision surgery. A distal centralizer is provided
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0822-2015·2014-12-24
Biomet Recalls Sirius Hip Stems Due to Packaging Mix-Up
Biomet is recalling nine Sirius Femoral Hip Stems because parts were mixed up prior to packaging and shipment.
Product
Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemented Device Common Name: Sirius Femoral Stem The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem, desi
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0075-2015·2014-10-22
Biomet Recalls Discovery Elbow Humeral Trial Due to Incorrect Etching
Biomet is recalling six Discovery Elbow Humeral Trials that were incorrectly manufactured as left-sided but etched as right-sided.
Product
Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety of elbow joint replacement prostheses intended for primary and revision joint arthoplasty for use in cemented applications. Elbow joint replacement components include humeral and ulnar components, and
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0058-2015·2014-10-15
Biomet Recalls Mamba Disposable Nitinol Needles Due to Breakage Risk
Biomet is recalling 164 Mamba Disposable Nitinol Needles because high friction may cause the needles to break during use.
Product
Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0057-2015·2014-10-15
Biomet Recalls Green Mamba Suture Passers Due to Needle Breakage Risk
Biomet, Inc. is recalling 12 units of Green Mamba Suture Passers because high friction may cause the needle to break during use.
Product
Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0056-2015·2014-10-15
Biomet Black Mamba Suture Passer Recalled Due to Needle Breakage Risk
Biomet, Inc. is recalling 15 units of Black Mamba Suture Passers because high friction may cause the needle to break during use.
Product
Black Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0021-2015·2014-10-15
Biomet Compress Face Reamer Recalled for Missing Helix Angle
Biomet, Inc. is recalling four Compress Face Reamer units because they were missing the required 4x21 degree helix angle.
Product
Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2242-2014·2014-08-27
Biomet Recalls Vanguard 360 Femoral Boss Reamers Due to Sizing Defect
Biomet is recalling 461 Vanguard 360 Femoral Boss Reamers because they were manufactured oversized and may not fit into mating components.
Product
Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 46581 USA
Category
Medical Device
Distribution
34 states
HighFDA (Devices)·Z-2212-2014·2014-08-20
Biomet Recalls Distal Radius Fracture Drill Guides Due to Jig Sticking
Biomet, Inc. is recalling 37 units of Distal Radius Fracture Repair System drill guides because they become stuck in the jig during use.
Product
Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common Name: Drill Guide DNP 3.3mm Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy P.O Box 988 Warsaw IN 46581
Category
Medical Device
Distribution
12 states
SevereFDA (Devices)·Z-1925-2014·2014-07-02
Biomet Recalls Discovery Elbow Prosthesis Due to Surface Finish Defect
Biomet, Inc. is recalling one unit of a Discovery Elbow prosthesis because the surface finish differs from specifications, potentially causing pain requiring surgery.
Product
DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement prostheses are intended for primary and revision joint arthroplasty for use in cemented applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1803-2014·2014-06-25
Biomet Recalls EZPass Suture Passer Due to Wire Buckling
Biomet, Inc. is recalling 102 EZPass Suture Passers because the nitinol wire may buckle and become kinked, making the instrument difficult to use.
Product
EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. Part numbers 904050, 904051, 904052, 904053, 904054, 904055, and 904056.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1838-2014·2014-06-25
Biomet G7 Acetabular System Positioning Guide Post Recalled for Fracture Risk
Biomet is recalling G7 Acetabular System Positioning Guide Posts because the guide rod may fracture during surgery, potentially causing a delay in the procedure.
Product
G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1837-2014·2014-06-25
Biomet G7 Acetabular System Positioning Guide Rod Recalled for Fracture Risk
Biomet is recalling G7 Acetabular System Positioning Guide Rods because they may fracture during surgery, potentially causing retained fragments or surgical delays.
Product
G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1802-2014·2014-06-25
Biomet Recalls EZPass Nylon Monofilament Suture Passers Due to Buckling
Biomet is recalling 100 units of EZPass Nylon Monofilament Suture Passers because the internal wire may buckle, making the instrument difficult to use.
Product
EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical Instrument Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1801-2014·2014-06-25
Biomet Recalls EZPass Suture Retriever Due to Nitinol Wire Buckling
Biomet is recalling 100 units of EZPass Suture Retriever instruments because the nitinol wire may buckle and become kinked, making the device difficult to use.
Product
EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Surgical Instrument, Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.
Category
Medical Device
Distribution
Distributed nationwide