Recall Z-2066-2023 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Waldemar Link GmbH & Co. KG (Mfg Site)
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/11
| Date | Jul 3, 2023 (initiated Dec 23, 2022) |
| Status | Open, Classified |
| Reason | Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation). |
| Root cause | Component change control |
| Action | LinkBio Corporation issued A Product Advisory Notice to consignees holding field inventory on 18-May-2023. The product is provided to the surgeon directly by the representative of the Distributor. Letter states reason for recall, health risk and action to take: Please ensure the surgical team is made aware of this issue before using one of the affected augments. While there is no safety impact due to this issue, there could be some confusion during assembly if the issue is not known in advance. No additional action is required by users beyond reinserting the screw in the correct orientation, a |
| Quantity | 20 units |
| Distribution | US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202924 | LinkSymphoKnee System Waldemar Link GmbH & Co. KG, May 13, 2021 |