Univation X Knee Implant Devices Recalled for Risk of Loosening
Aesculap Implant Systems is recalling Univation X System knee implant devices nationwide due to potential loosening. The malfunction could 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: This is an FDA Class II medical device with a confirmed malfunction (implant loosening). No reported illnesses or injuries are documented in the source. The hazard represents a risk of harm requiring surgical intervention, meeting the rubric criterion for 'High' severity.
Plain-English summary
Aesculap Implant Systems LLC is recalling Univation X System knee implant devices. The recall addresses potential loosening of the implant, which could require revision surgery.
The affected devices are meniscal components of the Univation X System with catalog numbers NL494 through NL499. All manufacturing lots have been distributed nationwide in the United States and are included in this recall.
Patients or healthcare providers seeking additional information should refer to the FDA's official recall documentation.
The recalled product
- Product
- Univation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL COMP.T1 RM/LM 11MM; NL495 UNIVATION F MENISCAL COMP.T2 RM/LM 11MM; NL496 UNIVATION F MENISCAL COMP.T3 RM/LM 11MM NL497 UNIVATION F MENISCAL COMP.T4 RM/LM 11MM NL498 UNIVATION…
- 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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