Greatbatch Medical: Medical Device Recall in 2016 - (Recall #: Z-1882-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 26, 2016

Date Posted: June 8, 2016

Recall Number: Z-1882-2016

Event ID: 73948

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.

Status: Terminated

Product Quantity: 2

Code Information:

6307760001

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated