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Acetabular Cup
WALDEMAR LINK GmbH & Co. KG · Model 105-315 · UDI-DI 04026575020140
JDI
Prescription
1
510(k) clearances
70,453
Adverse events (255 deaths)
255
Recalls
222
Facilities
Description
IP Polyethylene Acetabular Cup
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-09 | BioPro, Inc. | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is impla |
| 2025-08-28 | Howmedica Osteonics Corp. | a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may |
| 2025-07-11 | Onkos Surgical, Inc. | Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. |
| 2025-07-11 | Onkos Surgical, Inc. | Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. |
| 2025-07-11 | Onkos Surgical, Inc. | Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. |
| 2024-08-05 | Howmedica Osteonics Corp. | A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal. |
| 2024-07-02 | Zimmer, Inc. | Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF. |
| 2024-05-17 | Biomet, Inc. | 41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention |
| 2023-12-22 | Onkos Surgical, Inc. | Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. |
| 2023-12-22 | Onkos Surgical, Inc. | Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. |
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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.