The Recall Desk
HighFDA (Devices)·Z-2515-2021·Announced 2021-09-29

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.

What this means for you

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 UNIVATION
Manufacturer
Aesculap Implant Systems LLC
Category
Medical Device — Orthopedic implant
Hazard
  • implant-loosening

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.

Related recalls

Same category