Univation X System Knee Implants Recalled for Loosening Risk
Aesculap Implant Systems recalls Univation X System knee implants nationwide due to risk of loosening that could require revision surgery. All lots 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 is an FDA Class II recall of an orthopedic implant with identified risk of mechanical loosening that could necessitate revision surgery. No illnesses or injuries are reported in the source material, classifying this as a risk-of-harm scenario.
Plain-English summary
Aesculap Implant Systems LLC is recalling all lots of Univation X System knee implant devices distributed nationwide in the United States. The recalled devices are the Univation XF Tibia Cemented prosthesis in multiple sizes and configurations.
The devices are subject to a malfunction in which the implant may loosen over time. If loosening occurs, patients may require revision surgery to replace or repair the device.
Patients who have received these implants should consult their healthcare provider or orthopedic surgeon to discuss their individual circumstances and determine whether follow-up care or evaluation is appropriate.
The recalled product
- Product
- Univation X System knee implant devices as follows: Catalog/Product: NO156Z AS UNIVATION XF TIBIA CEMENTED T1 RM; NO157Z AS UNIVATION XF TIBIA CEMENTED T2 RM; NO158Z AS UNIVATION XF TIBIA CEMENTED T3 RM; NO159Z AS UNIVATION XF TIBIA CEMENTED T4 RM; NO160Z AS…
- 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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