Endo-Model Knee System - Instruments recallZ-2481-2023 · Waldemar Link GmbH & Co. KG (Mfg Site) · initiated Jul 26, 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
A crack in the weld of the rasp handle may lead to a fracture of the frontal sleeve when the rasp is further impacted or extracted. The rasp remains intact. The rasp would need to be pulled out by a clamp leading to a prolongation of surgery or modified surgery
FDA root cause category: Device Design
What the company is doing
LinkBio Corp.(US Importer) issued Urgent: Medical Device Recall letter via email on July 27, 203 to US Distributors . 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-2481-2023
- Status
- Open, Classified
- Initiated by the company
- Jul 26, 2023
- Posted by the FDA
- Aug 29, 2023
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Quantity
- 6 units
- Product code
- LXH
- Distribution
- IN,GA, TX
Product description
Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthroplasty surgical procedure Item Number: 17-5220/01
Code information (models, lots, serial numbers)
UDI-DI: 04026575284658 Lot Codes: C010108, C151519
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 17-5220/01WALDEMAR LINK GmbH & Co. KG · Orthopedic manual surgical instrument1 recall1 report
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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