Home / Recalls / Greatbatch Medical / Z-1882-2016

Z-1882-2016 Class II Terminated

Recalled by Greatbatch Medical — Plymouth, MN

Recall Details

Product Type
Devices
Report Date
June 8, 2016
Initiation Date
April 26, 2016
Termination Date
June 7, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2

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.

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 Pattern

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

Code Information

6307760001

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  • Z-0367-2017 Class I — Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl06 (August 2, 2016)
  • Z-1883-2016 Class II — Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non (April 26, 2016)
  • Z-1884-2016 Class II — Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed b (April 26, 2016)
  • Z-1614-2014 Class II — Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Orde (April 28, 2014)
  • Z-1119-2014 Class I — Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, (January 31, 2014)