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

Recall Z-0999-2024 — HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty

U.S. FDA — Device Enforcement · United States · 2023-12-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0999-2024
Date of alert
2023-12-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Howmedica Osteonics Corp.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07613327144086
Reported risk: Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility
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.

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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.