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

Recall Z-2548-2018 — AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer

U.S. FDA — Device Enforcement · United States · 2010-04-28 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2548-2018
Date of alert: 2010-04-28
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Cayenne Medical Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10130801

Reported risk: A review of product complaints in 2010 identified a trend for the Coring Removal Drill of premature wear and/or breakage. This recall occurred in 2013.

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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