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U.S. Department of Health and Human Services

Class 2 Device Recall Torque Limiting Adapter

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  Class 2 Device Recall Torque Limiting Adapter 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-1884-2016
Recall Event ID 73948
Product Classification Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
Product Torque Limiting Adapter:
Torque Limiting Attachment, Non Sterile, Distributed by Zimmer.

PRECIMED, Torque Limiting Adaptor, Non Sterile..

Customer Number/Model:
00-2360-080-00 T10232, T116245 T116245, TLA025-25 TLA025-25,
00-2360-080-05 T10233, MAC21003 T116430, TLA025-30 TLA025-30,
MAC21001 T112972, MAC21001 T13621, TLA025-20 TLA025-20.
Code Information 1000207 1001049 1001048 1000698 1000582 1000582 1001334 1001334 1002457 1002456 1002974 1002640 1003175 1003174 1003223 1003223 1003224 1003225 1003548 1003766 1003908 1004435 1004485 1004349 1004903 1005099 1004347 1005530 1005772 1005900 1009013 1008458 1009195 1009195 1009197 1009014 1009198 1009196 1009698 1009199 1009699 1009200 1009700 1011763 1010602 1012455 1012490 1013172 1013173 1013415 1013416 1013921 1013922 1514611 1614605 1714700 1953758 1953809 1953810 2124866 2073128 2116179 2141896 1953758 2150164 2157328 2209891 2302780 2302777 2302781 2302788 2362691 2407040 2407047 2407040 2407040 2898285 2898285 2898289 2971943 2904251 2919512 2938191 2978582 1004138 1004139 1004413 1004578 1004577 1004580 1004579 1005899 1005817 1009701 2324706 2920624 3092836 3092836 1006939   FC-002 FC-002 1012458 6280900001  8027435 8027436 8027434  
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 5952
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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