The Recall Desk
HighFDA (Devices)·Z-2512-2021·Announced 2021-09-29

Univation X Knee Implant Devices Recalled Due to Loosening Risk

Aesculap Implant Systems is recalling Univation X System knee implant devices (all lots, nationwide) because the implants may loosen, potentially requiring revision surgery. No injuries have been reported.

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 is an FDA Class II recall involving a risk-of-harm orthopedic implant that may loosen and require surgical revision. No injuries or hospitalizations have been reported in the source material.

Plain-English summary

Aesculap Implant Systems LLC is recalling the Univation X System knee implant devices distributed nationwide across the United States. All manufacturing lots are included in this recall.

The recalled devices include multiple catalog products, including NL488, NL489, NL490, NL491, NL492, and NL493 meniscal components. These implants may loosen over time, potentially resulting in the need for revision surgery to replace the affected device.

The FDA has classified this as a Class II recall.

The recalled product

Product
Univation X System knee implant devices as follows: Catalog/Product: NL488 UNIVATION F MENISCAL COMP.T1 RM/LM 10MM; NL489 UNIVATION F MENISCAL COMP.T2 RM/LM 10MM; NL490 UNIVATION F MENISCAL COMP.T3 RM/LM 10MM; NL491 UNIVATION F MENISCAL COMP.T4 RM/LM 10MM; NL492 UNIVATION
Manufacturer
Aesculap Implant Systems LLC
Category
Medical Device — Orthopedic / Knee Implant
Hazard
  • implant-loosening
  • device-failure

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