Recall Z-2048-2023 · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Waldemar Link GmbH & Co. KG (Mfg Site)
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right
| Date | Jun 30, 2023 (initiated Mar 18, 2021) |
| Status | Open, Classified |
| Reason | The firm discovered through customer complaints that device segments may not meet specifications. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143179 | The LINK® Endo-Model® Knee System Waldemar Link GmbH & Co. KG, Jan 30, 2015 |