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

Recall Z-0908-2015 — I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator guides the IM drill during IM Hole preparation. The instrument is positioned between the condyles and aligned with the anatomical axis. Pins can be placed in the IM hole locator to assist with additional

U.S. FDA — Device Enforcement · United States · 2014-11-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0908-2015
Date of alert: 2014-11-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: DePuy Orthopaedics, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10603295224389

Reported risk: Use of excessive force when impacting may lead to intra-operative femoral fracture.

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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