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Open, Classified

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

FDA Recall Z-0749-2024 · Posted 2024-01-18

Recall StatusOpen, Classified
Product CodeFZX
Date Initiated2023-11-30
Product Quantity1 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

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 [email protected] for any questions.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the state of NH.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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