Recall Z-0749-2024 ยท FZX Guide, Surgical, Instrument
Waldemar Link GmbH & Co. KG (Mfg Site)
Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05
| Date | Jan 18, 2024 (initiated Nov 30, 2023) |
| Status | Open, Classified |
| Reason | Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resected and not fit correctly leading to extended surgery time |
| Root cause | Under Investigation by firm |
| Action | Link Bio Corp. issued Urgent Medical Device Recall Letter via email on 11/30/23. 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 questions. |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the state of NH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.