The Recall Desk
HighFDA (Devices)·Z-2509-2021·Announced 2021-09-29

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.

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: 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 M
Manufacturer
Aesculap Implant Systems LLC
Category
Medical Device — Orthopedic Implant / Knee
Hazard
  • implant-loosening
  • device-malfunction

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