Recall Z-1373-2025 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Waldemar Link GmbH & Co. KG (Mfg Site)
Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12
| Date | Mar 17, 2025 (initiated Feb 14, 2025) |
| Status | Open, Classified |
| Reason | A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product. |
| Root cause | Labeling Change Control |
| Action | On February 21, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken by the Customer/User: Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return the affected product. Pre-paid shipping labels will be provided once the Distributor Reply Form is returned. Please return the product as soon as possible to the following address: LinkBio Corporation 69 King St Dover, NJ 07801 Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any questions. Adverse reactions or qualit |
| Quantity | 52 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IN, KS, MO, NJ, NV, OH TX, VA, WI and the countries of Germany, Italy, Spain, Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202924 | LinkSymphoKnee System Waldemar Link GmbH & Co. KG, May 13, 2021 |