| Class 2 Device Recall Nitinol Staple, Elastic Staple LargeSymmetrical | |
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
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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
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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 | 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 |
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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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