FDAApril 26, 2016device

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 T14380, MTO35175303 T8127.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

greatbatch medicalgreatbatch

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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