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Greatbatch Medical recalls Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: Customer Number/Model: MCL120014 T14000,
Recalled June 8, 2016 · FDA recall Z-1882-2016 · Greatbatch Medical
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. · FDA Class II
Units
2
Sold at
US: IN, MI, TX. OUS: GERMANY, FRANCE, ITALY, SWITZERLAND.
Description
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.
Product
Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: Customer Number/Model: MCL120014 T14000, TLT911-50-S20 TLT911-50-S20, TLT911-15-S01 TLT911-15-S01, TLTS0007-20-S19 TLTS0007-20-S19, TLT911-35-S01 TLT911-35-S01.
Manufacturer(s)
Greatbatch Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →