Date Initiated by Firm |
December 08, 2016 |
Date Posted |
January 06, 2017 |
Recall Status1 |
Terminated 3 on May 17, 2017 |
Recall Number |
Z-0960-2017 |
Recall Event ID |
76029 |
510(K)Number |
K153338
|
Product Classification |
Screw, fixation, bone - Product Code HWC
|
Product |
Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device. |
Code Information |
Lot: TSL003191, TSL003637, TSL004101, TSL004395 |
Recalling Firm/ Manufacturer |
Trilliant Surgical Ltd. 6721 Portwest Dr Ste 160 Houston TX 77024-8019
|
For Additional Information Contact |
Scott Bishop 800-495-2919
|
Manufacturer Reason for Recall |
Four lots of Tiger Screw Sterilization Tray Base Assemblies were released to the field with a printing error where k-wire description markings indicate diameters of 0.45 and 0.35 instead of 0.045" and 0.035", respectively.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Trilliant Surgical Ltd. sent an Urgent Medical Device Recall letter dated December 8, 2016, to all affected consignees. The letter instructed the consignees to 1) identify any/all affected product; 2) document any/all identified product via a provided response form and return to Trilliant Surgical; 3) exchange product upon receipt of replacements; and 4) return any/all affected product as originally identified and reported on the return response form. Customers with questions were instructed to call 800-495-2919. |
Quantity in Commerce |
50 units |
Distribution |
Nationwide Distribution |
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.
|
510(K) Database |
510(K)s with Product Code = HWC and Original Applicant = Trilliant Surgical, LTD
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