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.
FDA Recall Z-1882-2016 · Posted None
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Recalling FirmGreatbatch Medical
Recall StatusTerminated
Product CodeHWE
Date Initiated2016-04-26
Date Terminated2018-06-07
Product Quantity2
Reason for Recall
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.
Firm Action
Consignees were sent on 4/26/2016 a Greatbatch "Urgent Medical Device Recall" letter dated April 26, 2016. The letter described the product involved in the recall, the reason, and the risk to health. The letter advised consignees to identity and quarantine the product and to complete and return the Filed Recall Response Form. For questions contact your local Greatbatch Medical representative, at 1-763-951-8235, or e-mail [email protected].
Root Cause
Device Design
Distribution Pattern
US: IN, MI, TX. OUS: GERMANY, FRANCE, ITALY, SWITZERLAND.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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