Knee prosthesis femoral segment recalled for specification non-compliance
Waldemar Link is recalling 16 units of a knee prosthesis femoral segment due to specification non-compliance discovered through customer complaints. Patients and healthcare facilities should contact the manufacturer for guidance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a medical implant where specification failures create inherent risk of harm to patients, fitting the criterion of 'risk-of-harm products where injury has not yet been reported.' The FDA classified this as a Class II recall. While no illnesses or injuries have been reported in the source text, a prosthesis not meeting specifications poses potential risk of serious complications.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling 16 units of the LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right (Item No. 15-2979/01; UDI-DI: 04026575328093). The recalled units were distributed within the United States and internationally.
The manufacturer discovered through customer complaints that the device segments may not meet specifications. This was classified by the FDA as a Class II recall.
Patients and healthcare facilities with this product should contact Waldemar Link GmbH & Co. KG for further information and guidance regarding the recalled units.
The recalled product
- Product
- LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Hazard
- Affected units
- 16
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. 15-2979/01
- UDI-DI: 04026575328093.
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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