Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2509-2021 — 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 MENISCAL COMP.T5 RM/L

U.S. FDA — Device Enforcement · United States · 2021-03-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2509-2021
Date of alert: 2021-03-19
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Aesculap Implant Systems LLC
Product category: device
Product type: Devices

Reported risk: Malfunction- loosening of the implant resulting in a potential revision surgery

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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