Recall Z-2641-2023 · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Waldemar Link GmbH & Co. KG (Mfg Site)
MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination
| Date | Sep 26, 2023 (initiated Jul 14, 2023) |
| Status | Open, Classified |
| Reason | Product is labeled with incorrect offset. |
| Root cause | Under Investigation by firm |
| Action | On July 17, 2023, firm notified consignees via email. Customers were advised to return the affected product to LinkBio. Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any questions. |
| Quantity | 8 units |
| Distribution | Domestic distribution to AL, NJ, NV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200607 | LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters Waldemar Link GmbH & Co. KG, May 28, 2021 |