Knee Prosthesis Femoral Segment Recalled Due to Specification Compliance Issue
Waldemar Link is recalling 22 units of the LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left, because device segments may not meet specifications. The company discovered the issue through customer complaints.
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 knee prosthesis component where the manufacturer identified that device segments may not meet specifications. While no injuries or illnesses have been reported, specification non-compliance in a critical orthopedic implant poses a risk of harm to patients. Per the rubric, this qualifies as high-severity for a risk-of-harm medical device where injury has not been reported.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling 22 units of the LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left. The femoral segment is a component of a modular knee prosthesis system used in orthopedic surgery.
The company discovered through customer complaints that device segments may not meet specifications. This specification non-compliance poses a potential risk for implant failure or malfunction during use.
The affected devices were distributed domestically to Alabama, Georgia, Illinois, Indiana, Kansas, New Jersey, New York, and Texas. International distribution included Argentina, Australia, Austria, Brazil, Finland, France, Germany, India, Italy, Spain, and the United Kingdom. The recalled lot is identified by Item No. 15/2973/06 and UDI-DI: 04026575340736.
The recalled product
- Product
- LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Hazard
- specification-failure
- implant-defect
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. 15/2973/06
- UDI-DI: 04026575340736.
Distribution
Distributed in 8 states:
- AL
- GA
- IL
- IN
- KS
- NJ
- NY
- TX
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03