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

Recall Z-0377-2020 — ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (01)18032568031911

U.S. FDA — Device Enforcement · Italy · 2018-09-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0377-2020
Date of alert
2018-09-27
Country / jurisdiction
Italy
Risk level
Class II
Risk type
recall
Brand
Orthofix Srl
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
18032568031911
Reported risk: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
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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