Knee Prosthesis System Components Recalled for Specification Non-Compliance
Waldemar Link GmbH & Co. KG is recalling 21 units of LINK Endo-Model Modular Knee Prosthesis System Femoral Segment components because they may not meet manufacturing specifications. No injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with no reported injuries. The hazard—specification non-compliance—is theoretical, making this a risk-of-harm product without confirmed harm.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling 21 units of the LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right. This is an orthopedic implant component used in knee replacement procedures.
The manufacturer discovered through customer complaints that device segments may not meet manufacturing specifications. The FDA classified this as a Class II recall. As of this notice, no injuries or illnesses have been reported.
The recalled components were distributed domestically to Alabama, Georgia, Illinois, Indiana, Kansas, New Jersey, New York, and Texas. Internationally, they were distributed to Argentina, Australia, Austria, Brazil, Finland, France, Germany, India, Italy, Spain, and the United Kingdom. The devices can be identified by UDI-DI 04026575340699 and Item No. 15-2973/05.
The recalled product
- Product
- LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Affected units
- 21
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Item No. 15-2973/05
- UDI-DI: 04026575340699.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Waldemar Link GmbH & Co. KG (Mfg Site) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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