Univation X knee implant devices recalled for potential loosening
Aesculap Implant Systems is recalling Univation X System knee implants nationwide due to potential loosening that may require revision surgery.
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: FDA Class II orthopedic implant recall involving a known malfunction (loosening) that could necessitate revision surgery. Qualifies as a risk-of-harm product where injury has not yet been reported, per the severity rubric criterion for score 3.
Plain-English summary
Aesculap Implant Systems LLC is recalling Univation X System knee implant devices due to potential loosening of the implants. The recalled devices include meniscal components with catalog numbers NL470, NL471, NL472, NL473, NL474, and NL475.
The implants may malfunction and loosen, which could result in the need for revision surgery. All lots of the recalled devices have been distributed nationwide throughout the United States.
Patients who have received these implants should contact their healthcare provider for evaluation and guidance regarding their specific situation.
The recalled product
- Product
- Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM; NL471 UNIVATION F MENISCAL COMP.T2 RM/LM 7MM; NL472 UNIVATION F MENISCAL COMP.T3 RM/LM 7MM NL473 UNIVATION F MENISCAL COMP.T4 RM/LM 7MM NL474 UNIVATION F…
- Manufacturer
- Aesculap Implant Systems LLC
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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