The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2510-2021·Announced 2021-09-29

Aesculap Univation X System knee implant devices recalled for potential loosening

Aesculap is recalling Univation X System knee implants nationwide because they may loosen, potentially requiring revision surgery.

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 medical device recall for knee implants with risk of harm (loosening potentially requiring revision surgery). No injuries or hospitalizations are reported in the source text, meeting the criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Aesculap Implant Systems LLC is recalling Univation X System knee implant devices distributed nationwide in the United States. The recall includes meniscal component models NL476 through NL481 and affects all manufactured lots.

The devices may loosen, which could necessitate revision surgery. Patients who have received these implants should contact their healthcare provider with any concerns about their device or to discuss their implant status.

The recalled product

Product
Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM; NL477 UNIVATION F MENISCAL COMP.T2 RM/LM 8MM; NL478 UNIVATION F MENISCAL COMP.T3 RM/LM 8MM; NL479 UNIVATION F MENISCAL COMP.T4 RM/LM 8MM; NL480 UNIVATION F…
Manufacturer
Aesculap Implant Systems LLC
Category
Medical Device — Orthopedic Implant
Hazard

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.

See all 8 products in this recall →

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