LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right
FDA device recall Z-2048-2023 · posted 2023-06-30 · Open, Classified
Recall details
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Reason for recall
- The firm discovered through customer complaints that device segments may not meet specifications.
- Action taken
- The firm sent recall notifications by email to consignees on 03/24/2021. Customers were asked to discontinue use of affected devices and to return any that remain in stock to LinkBio Corporation, Waldemar Link's US Distributor, immediately. Credit or replacement was issued for the returned product upon receipt. Any questions about this recall event are to be directed to Nikhil Mangale at 1-973-625-1333 ext. 116 from Monday through Friday from 8:00 am to 5:30 pm, or by email to n.mangale@linkbio.com.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- KRO
- Quantity affected
- 16 units
- Distribution
- Domestic: AL, GA, IL, IN, KS, NJ, NY, and TX. Foreign: Argentina, Australia, Austria, Brazil, Finland, France, Germany, India, Italy, Spain, and United Kingdom.
- Date initiated
- 2021-03-18
- Date posted
- 2023-06-30
- Location
- Norderstedt, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| The LINK® Endo-Model® Knee System (K143179) | Waldemar Link GmbH & Co. KG | 2015-01-30 |