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

Recall Z-1103-2021 — Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.

U.S. FDA — Device Enforcement · United States · 2021-01-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1103-2021
Date of alert: 2021-01-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: DePuy Orthopaedics, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 129453216

Reported risk: The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.

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.

Recall Z-1103-2021 — Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.

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