Univation X System knee implants recalled for loosening risk
Aesculap Implant Systems is recalling Univation X System knee implants because they may loosen, potentially requiring additional surgery. The recall affects devices distributed nationwide.
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 FDA Class II medical device recall describes a malfunction (implant loosening) that may require revision surgery. No illnesses or injuries have been reported. Per the rubric, this qualifies as High (3): a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Aesculap Implant Systems LLC is recalling Univation X System knee implant devices (catalog numbers NL482 through NL487) due to a documented malfunction.
The implants may loosen in the knee, which could require revision surgery to correct. The FDA classified this as a Class II recall.
The devices were distributed nationwide in the United States, affecting all manufacturing lots.
Patients who have received these implants should contact their surgeon or healthcare provider with any concerns. Healthcare providers should notify patients if they have implanted any of the recalled devices.
The recalled product
- Product
- Univation X System knee implant devices as follows: Catalog/Product: NL482 UNIVATION F MENISCAL COMP.T1 RM/LM 9MM; NL483 UNIVATION F MENISCAL COMP.T2 RM/LM 9MM; NL484 UNIVATION F MENISCAL COMP.T3 RM/LM 9MM; NL485 UNIVATION F MENISCAL COMP.T4 RM/LM 9MM; NL486 UNIVATION F ME
- Manufacturer
- Aesculap Implant Systems LLC
- Hazard
- implant-loosening
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 (1)
- All lots
Distribution
Distributed nationwide across the United States.
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