| Class 2 Device Recall Nitinol Staple, Elastic Staple SmallSymmetrical | |
Date Initiated by Firm | April 13, 2018 |
Create Date | June 20, 2018 |
Recall Status1 |
Terminated 3 on January 22, 2021 |
Recall Number | Z-2265-2018 |
Recall Event ID |
80099 |
510(K)Number | K112794 |
Product Classification |
Staple, fixation, bone - Product Code JDR
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Product | Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f) ES-10x14; g) ES-10x15 |
Code Information |
Lot #: a) 021C, 00T3, 050501, 10505-01, 00501, 179201, 17920, 179202, 179203; b) 26401, 0219, 02613, 0216, 026B, 050502, 10505-02, 01P2, 24601, 179302, 179301, 179303, 264-01, 179304, 317003; c) R884, 0266, 050503, 10505-03, 179501, 004J, 00A0, 173501; d) 26402, 264-02, 2015, 050508, 10505-08, 24602, 11799, 23402, 0215, 1799, 179901, 179304, 1179; e) 26403, 03UQ, 050509, 10505-09, 24603, 11802, 1180202, 180202, 80202, 180203, 108202, 263401, 23401; f) 004K, 0093; g) 004L, 2012BB |
Recalling Firm/ Manufacturer |
TriMed Inc. 27533 Avenue Hopkins Santa Clarita CA 91355-3910
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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 | 1,194 |
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 |
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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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510(K) Database | 510(K)s with Product Code = JDR
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