Recall Z-1674-2023 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Linkbio Corp.
LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-325/13
| Date | Jun 1, 2023 (initiated Apr 25, 2023) |
| Status | Open, Classified |
| Reason | Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left). |
| Root cause | Under Investigation by firm |
| Action | LinkBio Corp. issued Urgent Medical Device Recall on 4/25/23 via email to Distributors. Letter states reason for recall, health risk and action to take: 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 question |
| Quantity | 11 units |
| Distribution | US Nationwide Distribution - AL, GA, IL, IN, LA, 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 |