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

Recall Z-2364-2012 — REF 101-45-20NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mmUse with 20mm ScrewSTERILEEXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hi

U.S. FDA — Device Enforcement · United States · 2012-01-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2364-2012
Date of alert: 2012-01-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Exactech, Inc.
Product category: device
Product type: Devices

Reported risk: Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.

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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