Endo-Model Knee System - Instruments recallZ-0749-2024 · Waldemar Link GmbH & Co. KG (Mfg Site) · initiated Nov 30, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Waldemar Link GmbH & Co. KG (Mfg Site) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0749-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 30, 2023
- Posted by the FDA
- Jan 18, 2024
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Quantity
- 1 unit
- Product code
- FZX
- Distribution
- US Nationwide distribution in the state of NH.
Product description
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
Code information (models, lots, serial numbers)
UDI-DI :04026575245253 Lot / Serial Number: C306165
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Endo-Model Knee System - Instruments 15-2530/05WALDEMAR LINK GmbH & Co. KG · Guide, surgical, instrument1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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