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U.S. Department of Health and Human Services

Class 2 Device Recall Nitinol Staple, Elastic Staple LargeAsymmetrical

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 Class 2 Device Recall Nitinol Staple, Elastic Staple LargeAsymmetricalsee related information
Date Initiated by FirmApril 13, 2018
Create DateJune 20, 2018
Recall Status1 Terminated 3 on January 22, 2021
Recall NumberZ-2262-2018
Recall Event ID 80099
510(K)NumberK112794 
Product Classification Staple, fixation, bone - Product Code JDR
ProductNitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19
Code Information Lot #: a) R901, 03UU, 050522, 10505-22, 0344, 0051, 11805, 00AJ,  10505-23, 050523, 180502, 180901,  180503, 18902; b) 03UV, 050523, 10505-23, 00AJ, 0052, 180901, 11809, 180902, 26408, 264-08, 11805,  180502,  118901
FEI Number 3001236812
Recalling Firm/
Manufacturer		 TriMed Inc.
27533 Avenue Hopkins
Santa Clarita CA 91355-3910
For Additional Information ContactAnnie Cranston
800-633-7221
Manufacturer Reason
for Recall		During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized.
FDA Determined
Cause 2		Process design
ActionOn 04/13/18, customer recall communication forms were sent via mail informing customers to quarantine effected devices, call the manufacturer to arrange device return at 800-633-7221, and report adverse events to the FDA's MedWatch.
Quantity in Commerce532
DistributionU.S.: IL, UT, PA, NJ, WA, TX, NV, CA, NC, MS, KS, MO, MN, FL; OUS: Australia and Sweden
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = JDR
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