Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthropla

FDA device recall Z-0749-2024 · posted 2024-01-18 · Open, Classified

Recall details

Recalling firm

Waldemar Link GmbH & Co. KG (Mfg Site)

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

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

FZX

Quantity affected

1 unit

Distribution

US Nationwide distribution in the state of NH.

Date initiated

2023-11-30

Date posted

2024-01-18

Location

Norderstedt, Germany