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AGC V2 TOTAL KNEE SYSTEM
Biomet Orthopedics, LLC · Model 155022 · UDI-DI 05019279390434
JWH
Prescription
1
510(k) clearances
158,735
Adverse events (262 deaths)
985
Recalls
318
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-10-02 | CORIN MEDICAL, LTD. | Potential malfunction of the Modular Handles where the locking mechanism may fail. Any mating instruments already engaged to the handle will not be able to be disengaged, and the h |
| 2026-07-30 | Howmedica Osteonics Corp. | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels o |
| 2026-05-20 | United Orthopedic Corp. | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. |
| 2026-02-16 | Encore Medical, LP | Due to packaging discrepancy with incorrect product size mixed up. |
| 2026-02-16 | Encore Medical, LP | Due to packaging discrepancy with incorrect product size mixed up. |
| 2026-01-15 | Encore Medical, LP | Knee and Humeral socket implants contain incorrect labeling. |
| 2026-01-05 | Encore Medical, LP | 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discr |
| 2025-07-31 | Waldemar Link GmbH & Co. KG (Mfg Site) | Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect. |
| 2025-07-09 | Encore Medical, LP | Knee implants contain incorrect labeling (size and/or side incorrect) |
| 2025-07-09 | Encore Medical, LP | Knee implants contain incorrect labeling (size and/or side incorrect) |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.