Endo-Model Modular Knee Prosthesis System recallZ-2046-2023 · Waldemar Link GmbH & Co. KG (Mfg Site) · initiated Mar 18, 2021
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
The firm discovered through customer complaints that device segments may not meet specifications.
FDA root cause category: Device Design
What the company is doing
The firm sent recall notifications by email to consignees on 03/24/2021. Customers were asked to discontinue use of affected devices and to return any that remain in stock to LinkBio Corporation, Waldemar Link's US Distributor, immediately. Credit or replacement was issued for the returned product upon receipt. Any questions about this recall event are to be directed to Nikhil Mangale at 1-973-625-1333 ext. 116 from Monday through Friday from 8:00 am to 5:30 pm, or by email to [email protected].
Recall details
- Recall number
- Z-2046-2023
- Status
- Open, Classified
- Initiated by the company
- Mar 18, 2021
- Posted by the FDA
- Jun 30, 2023
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Quantity
- 21 units
- Product code
- KRO
- FDA submissions
- K143179
- Distribution
- Domestic: AL, GA, IL, IN, KS, NJ, NY, and TX. Foreign: Argentina, Australia, Austria, Brazil, Finland, France, Germany, India, Italy, Spain, and United Kingdom.
Product description
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right
Code information (models, lots, serial numbers)
Item No. 15-2973/05; UDI-DI: 04026575340699.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Endo-Model Modular Knee Prosthesis System 15-2973/05WALDEMAR LINK GmbH & Co. KG · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 92500).
- Z-2047-2023 · Open, ClassifiedLINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left
- Z-2048-2023 · Open, ClassifiedLINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right
- Z-2049-2023 · Open, ClassifiedLINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left
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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