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Recall Observatory FDA recall evidence

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.

Z-1882-2016

April 26, 2016

Class II

Product summary

Firm
Greatbatch Medical
Event
Event 73948
Status
Terminated
Classification
Class II
Quantity
2
Official record key
device-enforcement:Z-1882-2016

Official wording

Reason: 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.

Code information: 6307760001

Distribution pattern: US: IN, MI, TX. OUS: GERMANY, FRANCE, ITALY, SWITZERLAND.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.