BIOMET
1343 recalls · 82 clearances · 80 adverse events · 20 inspections · 5 compliance actions · aggregated across 2 source records
Scorecard
Events per device across the 27-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0.30 ▼
8 in the last 12 months
Higher volume than 96% of companies with 10+ devices
Recalls per device
0.074 →
2 in the last 12 months
Higher volume than 100% of companies with 10+ devices
These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.
Devices
27 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| BIOMET® BONE CEMENT R | 110035368 | LOD | 00887868214578 | 98 |
| Refobacin® Bone Cement R | 110034355 | LOD MBB | 00880304990197 | 79 |
| BIOMET® BONE CEMENT R | 110035371 | LOD | 00887868214608 | 1 |
| Optivac Nozzle Slim | 4154 | KIH | 07350023771092 | 1 |
| REFOBACIN® BONE CEMENT R | 110034358 | LOD MBB | 00880304990227 | 1 |
| REFOBACIN® BONE CEMENT R | 110034357 | LOD MBB | 00880304990210 | 1 |
| REFOBACIN® BONE CEMENT R | 110034356 | LOD MBB | 00880304990203 | 1 |
| Angled Nozzle | 4149 | KIH | 07350023771429 | 0 |
| Cement Delivery System | 110030623 | KIH | 00880304810990 | 0 |
| Cement Delivery System | 4146 | KIH | 07350023771719 | 0 |
| Knee Cementation Nozzle | 4312 | KIH | 07350023771214 | 0 |
| OPTIVAC FUSION | 419000 | JDZ | 00880304488380 | 0 |
| Optigun II | 419300 | KIH | 00880304371019 | 0 |
| Optigun Ratchet | 419500 | KIH | 07350023771788 | 0 |
| Optivac Kit, 120 gram Triple Mix | 418300 | JDZ | 00880304371002 | 0 |
| Optivac Kit, 120 gram Triple Mix | 417300 | JDZ | 00880304370623 | 0 |
| Optivac Kit, 40 gram single Mix | 417100 | JDZ | 00880304370579 | 0 |
| Optivac Kit, 80 gram Double Mix | 417200 | JDZ | 00880304370609 | 0 |
| Optivac Kit, 80 gram Double Mix | 418200 | JDZ | 00880304370999 | 0 |
| Optivac Nozzle Revision | 4155 | KIH | 07350023771108 | 0 |
| Optivac Total Hip Kit | 417000 | JDZ | 00880304370562 | 0 |
| Optivac Total Hip Kit | 418000 | JDZ | 00880304370647 | 0 |
| Right-Angle Nozzle | 414900 | KIH | 00880304370326 | 0 |
| T.E.S.S® LID | A1700382 | FSM | 03599870108505 | 0 |
| TESS BASE | A1700380 | FSM | 03599870107898 | 0 |
| TESS BOTTOM INSERT HEMI | A1700384 | FSM | 08428898898332 | 0 |
| TESS TOP INSERT HEMI | A1700386 | FSM | 08428898898349 | 0 |
Compliance actions
FDA warning letters and enforcement actions (full history).
| Date | Type | Action | Firm |
|---|---|---|---|
| 2018-08-24 | WL | Warning Letter | Biomet, Inc. |
| 2018-08-24 | WL | Warning Letter | Biomet, Inc. |
| 2015-06-03 | WL | Warning Letter | Zhejiang Biomet Medical Products Co. Ltd. |
| 2010-07-27 | WL | Warning Letter | Biomet, Inc. |
| 2010-07-27 | WL | Warning Letter | Biomet, Inc. |
Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|---|---|---|---|
| 3006946279 | BIOMET FRANCE | Valence Drome, FR | NAI | |
| 3002806535 | BIOMET UK LTD. | BRIDGEND, GB | VAI | |
| 1825034 | BIOMET, INC. | WARSAW, IN, US | VAI | |
| 3007923096 | Changzhou Biomet Medical Devices Co., Ltd. | Changzhou City Jiangsu, CN | NAI | |
| 1216032 | Citra Labs LLC | Braintree, MA, US | — | |
| 3006801265 | Zhejiang Biomet Medical Products Co., Ltd. | Jinhua Zhejiang, CN | NAI |