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.
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 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…
- Manufacturer
- Aesculap Implant Systems LLC
- Hazard
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.
Part of a larger recall action
This product is one of 8 recalled by Aesculap Implant Systems LLC 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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