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.
This recall has been terminated (originally issued April 26, 2016).
- Company
- Greatbatch Medical
- Recall Initiated
- April 26, 2016
- Terminated
- June 7, 2018
- Recall Number
- Z-1882-2016
- Quantity
- 2
- Firm Location
- Plymouth, MN
- Official Source
- View on FDA website ↗
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.
Distribution
US: IN, MI, TX. OUS: GERMANY, FRANCE, ITALY, SWITZERLAND.
Lot / Code Info
6307760001
Root Cause
Device Design
Action Taken
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 FieldActionCenter@Greatbatch.com.