Univation X System Knee Implant Devices Recalled for Loosening Risk
Aesculap Implant Systems is recalling Univation X System knee implant devices because they may loosen, potentially requiring revision surgery. All lots distributed in the US are affected.
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 recall involves implant loosening, a risk-of-harm condition with no reported illnesses or injuries. Per the rubric, recalls with theoretical hazards and no reported harm are scored as High (3).
Plain-English summary
Aesculap Implant Systems LLC is recalling all lots of Univation X System knee implant devices due to a risk of malfunction. The recalled devices include multiple catalog numbers (NO180Z through NO189Z) used in knee replacement procedures.
The implants may loosen over time, which could require revision surgery. The recall affects patients who have received these devices. All lots were distributed nationwide throughout the United States.
Patients concerned about their implants should consult their surgeon or healthcare provider.
The recalled product
- Product
- Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM; NO181Z AS UNIVATION XF FEMUR CEMENTED F2 RM; NO182Z AS UNIVATION XF FEMUR CEMENTED F3 RM; NO183Z AS UNIVATION XF FEMUR CEMENTED F4 RM; NO184Z AS…
- 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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