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Class 2 Device Recall Nitinol Staple, Elastic Staple SmallAsymmetrical |
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Date Initiated by Firm |
April 13, 2018 |
Create Date |
June 20, 2018 |
Recall Status1 |
Terminated 3 on January 22, 2021 |
Recall Number |
Z-2264-2018 |
Recall Event ID |
80099 |
510(K)Number |
K112794
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Product Classification |
Staple, fixation, bone - Product Code JDR
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Product |
Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19; d) ES-12x13x15; e) ES-12x15x17; f) ES-12x16x19; g) ES-15x13x16 |
Code Information |
Lot #: a) 00A5, 26406, R889, 03UJ, 003UJ, 050514, 10505-14, 264-06, 004P, 26404, 10505-14, 226001, 264, 26401, 22600; b) 004S; c) 004R; d) 050518, 10505-18, 021G, 021F, 0505018, 11788, 080818, 178801, 17881, 316801; e) R895, 050519, 10505-19, 2012BJ, 004V, 009D, 0505019, 178901, 180502, 17890, 1178901, 00AB, 0090, 0091, 78901; f) 009E, 11264, R896, 004W, 183701, 11837, 050520, 10505-20, 178901, 10505-20, 083701, 118337, 08370, 26407, 264-07; g) 03UR, 26408, 264-08, 050521, 26406, 264-06, 1050521, 179001, 10505-21, 179002 |
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
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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.
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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 |
706 |
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 and Original Applicant = TRIMED, INC.
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