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U.S. Department of Health and Human Services

Class 2 Device Recall Nitinol Staple, Elastic Staple LargeSymmetrical

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  Class 2 Device Recall Nitinol Staple, Elastic Staple LargeSymmetrical see related information
Date Initiated by Firm April 13, 2018
Create Date June 20, 2018
Recall Status1 Terminated 3 on January 22, 2021
Recall Number Z-2263-2018
Recall Event ID 80099
510(K)Number K112794  
Product Classification Staple, fixation, bone - Product Code JDR
Product Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22
Code Information Lot #: a) R900, 009J, 050511, 00AG, 0095, 183601, 10505-11, 193601; b) R903, 26404, 264-04, 03NK, 050512, 10505-12, 24604, 11811, 181102, 181103, 188803; c) 26405, 009N, 00AL, R904, 00A1, 00PN, 050513, 10505-13, 183501, 83501, 264-05, 004L,
Recalling Firm/
Manufacturer		 TriMed Inc.
27533 Avenue Hopkins
Santa Clarita CA 91355-3910
For Additional Information Contact Annie 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
Action On 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 Commerce 323
Distribution U.S.: IL, UT, PA, NJ, WA, TX, NV, CA, NC, MS, KS, MO, MN, FL; OUS: Australia and Sweden
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.
510(K) Database 510(K)s with Product Code = JDR and Original Applicant = TRIMED, INC.
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