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.

101–125 of 255

HighFDA (Devices)·Z-2145-2020·2020-06-03
Biomet Recalls RingLoc Hip System Components Due to Endotoxin Levels
Biomet, Inc. is recalling specific RingLoc Hip System components due to potential elevated endotoxin levels that exceed specification limits.
Product
Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip System, Acetabular Cup, 28 MM X 47 MM 3) XL-105916 588500 RingLoc Hip System, Acetabular Liner, 36 MM, Size 26 Product Usage: Hemi hip arthrop
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2149-2020·2020-06-03
Biomet Recalls AGC Knee System Tibial Components Due to Endotoxin Levels
Biomet, Inc. is recalling 54 units of AGC Knee System PS Molded Tibial Components because they may contain elevated endotoxin levels that exceed specification limits.
Product
Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155330 Knees AGC Knee System PS Molded Tibial Component, 14 MM X 70 MM 155344 Knees AGC Knee System PS Molded Tibial Co
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2155-2020·2020-06-03
Biomet Recalls Vanguard M Partial Knee System MonoBlock Tibial Trays
Biomet, Inc. is recalling 105 units of Vanguard M Partial Knee System MonoBlock Tibial Trays due to potential elevated endotoxin levels.
Product
Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8 US154722 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, D5 US154725 Knees Vanguard M Partial Knee System MonoBlock Tibial T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2144-2020·2020-06-03
Biomet Recalls Shoulder Implant Components Due to Endotoxin Levels
Biomet is recalling 122 units of specific shoulder implant components due to potential endotoxin levels exceeding specifications.
Product
Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 36 MM, +3MM Standard Product Usag
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1750-2020·2020-04-29
Biomet Shoulder Surgery Pliers Recalled for Sterility Concerns
Biomet is recalling 125 units of Comprehensive Humeral Tray Taper Extraction Pliers replacement tips due to unknown bioburden levels that may affect sterility.
Product
Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff d
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1660-2020·2020-04-15
Biomet Shoulder Cement Spacer Mold Recalled for Cleaning Process Concerns
Biomet, Inc. is recalling 230,001 units of StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
Category
Medical Device
Distribution
49 states
HighFDA (Devices)·Z-1647-2020·2020-04-15
Biomet Hip Stem Cement Spacer Mold Recalled for Cleaning Process Concerns
Biomet is recalling 230,001 hip stem cement spacer molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.
Category
Medical Device
Distribution
49 states
HighFDA (Devices)·Z-1643-2020·2020-04-15
Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns
Biomet is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes.
Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
Category
Medical Device
Distribution
49 states
HighFDA (Devices)·Z-1641-2020·2020-04-15
Biomet Hip Cement Spacer Mold Recalled for Cleaning Process Concerns
Biomet is recalling StageOne Hip Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.
Category
Medical Device
Distribution
49 states
HighFDA (Devices)·Z-1654-2020·2020-04-15
Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns
Biomet, Inc. is recalling 230,001 units of StageOne Hip Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.
Category
Medical Device
Distribution
49 states
HighFDA (Devices)·Z-1638-2020·2020-04-15
Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns
Biomet, Inc. is recalling 230,001 units of StageOne Hip Cement Spacer Molds because of potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
Category
Medical Device
Distribution
49 states
HighFDA (Devices)·Z-1642-2020·2020-04-15
Biomet Recalls StageOne Hip Cement Spacer Molds Due to Cleaning Concerns
Biomet is recalling StageOne Hip Cement Spacer Molds because the cleaning process may have been insufficient or inadequately monitored.
Product
BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1657-2020·2020-04-15
Biomet Shoulder Cement Spacer Mold Recalled for Cleaning Process Concerns
Biomet is recalling 230,001 units of StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring.
Product
BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1640-2020·2020-04-15
Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns
Biomet, Inc. is recalling StageOne Hip Cement Spacer Molds because of a potentially insufficient cleaning process or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1666-2020·2020-04-15
Biomet Recalls Knee Tibial Cement Spacer Molds Due to Cleaning Concerns
Biomet is recalling 230,001 units of StageOne Knee Tibial Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1645-2020·2020-04-15
Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns
Biomet is recalling 230,001 hip stem cement spacer molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1639-2020·2020-04-15
Biomet Recalls StageOne Hip Cement Spacer Molds Due to Cleaning Concerns
Biomet is recalling 230,001 units of StageOne Hip Cement Spacer Molds because of potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1648-2020·2020-04-15
Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns
Biomet, Inc. is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes.
Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1651-2020·2020-04-15
Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns
Biomet, Inc. is recalling specific lots of StageOne Select Hip Stem Cement Spacer Molds because of a potentially insufficient cleaning process or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1653-2020·2020-04-15
Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns
Biomet, Inc. is recalling 230,001 units of BIOMET StageOne Hip Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1650-2020·2020-04-15
Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns
Biomet is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring.
Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1652-2020·2020-04-15
Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns
Biomet, Inc. is recalling specific lots of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring.
Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1659-2020·2020-04-15
Biomet Shoulder Cement Spacer Mold Recalled for Cleaning Process Concerns
Biomet is recalling StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1646-2020·2020-04-15
Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns
Biomet, Inc. is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes.
Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1661-2020·2020-04-15
Biomet Shoulder Cement Spacer Mold Recalled for Cleaning Process Concerns
Biomet is recalling StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.
Category
Medical Device
Distribution
49 states