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
- Recall Initiated
- November 30, 2023
- Posted
- January 18, 2024
- Recall Number
- Z-0749-2024
- Quantity
- 1 unit
Reason for Recall
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
Distribution
US Nationwide distribution in the state of NH.
Lot / Code Info
UDI-DI :04026575245253 Lot / Serial Number: C306165
Root Cause
Under Investigation by firm
Action Taken
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.