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U.S. Department of Health and Human Services

Class 2 Device Recall Torque Limiting Handle

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  Class 2 Device Recall Torque Limiting Handle see related information
Date Initiated by Firm April 26, 2016
Create Date June 01, 2016
Recall Status1 Terminated 3 on June 07, 2018
Recall Number Z-1882-2016
Recall Event ID 73948
Product Classification Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
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.
Code Information 6307760001 
Recalling Firm/
Manufacturer		 Greatbatch Medical
2300 Berkshire Ln N
Plymouth MN 55441-4575
For Additional Information Contact Greatbatch Medical representative
763-951-8235
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
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 FieldActionCenter@Greatbatch.com.
Quantity in Commerce 2
Distribution US: IN, MI, TX. OUS: GERMANY, FRANCE, ITALY, SWITZERLAND.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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