MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclina
FDA device recall Z-2641-2023 · posted 2023-09-26 · Open, Classified
Recall details
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Reason for recall
- Product is labeled with incorrect offset.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- LPH
- Quantity affected
- 8 units
- Distribution
- Domestic distribution to AL, NJ, NV.
- Date initiated
- 2023-07-14
- Date posted
- 2023-09-26
- Location
- Norderstedt, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LINK MobileLinkĀ® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters (K200607) | Waldemar Link GmbH & Co. KG | 2021-05-28 |