The Recall Desk
HighFDA (Devices)·Z-2513-2021·Announced 2021-09-29

Univation X Knee Implant Devices Recalled for Risk of Loosening

Aesculap Implant Systems is recalling Univation X System knee implant devices nationwide due to potential loosening. The malfunction could 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: This is an FDA Class II medical device with a confirmed malfunction (implant loosening). No reported illnesses or injuries are documented in the source. The hazard represents a risk of harm requiring surgical intervention, meeting the rubric criterion for 'High' severity.

Plain-English summary

Aesculap Implant Systems LLC is recalling Univation X System knee implant devices. The recall addresses potential loosening of the implant, which could require revision surgery.

The affected devices are meniscal components of the Univation X System with catalog numbers NL494 through NL499. All manufacturing lots have been distributed nationwide in the United States and are included in this recall.

Patients or healthcare providers seeking additional information should refer to the FDA's official recall documentation.

The recalled product

Product
Univation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL COMP.T1 RM/LM 11MM; NL495 UNIVATION F MENISCAL COMP.T2 RM/LM 11MM; NL496 UNIVATION F MENISCAL COMP.T3 RM/LM 11MM NL497 UNIVATION F MENISCAL COMP.T4 RM/LM 11MM NL498 UNIVATION F
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