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

Recall Z-1883-2016 — Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only. Screwdriver: Customer Number/Model: 804-03-038 T11623, T14001 T14001, MTO35173507 T14378, MTO375173506 T14379, MTO35173505 T1438

U.S. FDA — Device Enforcement · United States · 2016-04-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1883-2016
Date of alert
2016-04-26
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Greatbatch Medical
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
2743160001
Reported risk: Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SAL) of 10-6 is not achieved on torque limiting devices when subjected to steam sterilization cycles identified in the Instruction For Use (IFU) provided with the device.
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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