|
Class 2 Device Recall Tiger Large Cannulated Headless Screw System |
|
Date Initiated by Firm |
September 02, 2016 |
Date Posted |
November 17, 2016 |
Recall Status1 |
Terminated 3 on May 19, 2017 |
Recall Number |
Z-0609-2017 |
Recall Event ID |
75187 |
510(K)Number |
K112737
|
Product Classification |
Screw, fixation, bone - Product Code HWC
|
Product |
Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-70-110 QTY 30 LOT TSL003721 2016-03-29 Trilliant Surgical, LTD" |
Code Information |
Lot TSL003721 |
Recalling Firm/ Manufacturer |
Trilliant Surgical Ltd. 6721 Portwest Dr Ste 160 Houston TX 77024-8019
|
For Additional Information Contact |
Krystal Johnson 713-388-6055
|
Manufacturer Reason for Recall |
Screws were identified as having the incorrect part number and lot number marked upon them. The part number incorrectly indicated a length of 115 mm rather than 110 mm. The lot number incorrectly indicated lot number of TSL003765 rather than TSL003721.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
The firm sent out written notifcation of the recall on 9/2/16; the letter instructed the consignees to discontinue use of the affected lot, quarantine, and return product of the affected lot in accordance with an included acknowledgement sheet. |
Quantity in Commerce |
11 |
Distribution |
CA, AZ, WI, FL, NJ, OH |
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 = HWC and Original Applicant = TRILLIANT SURGICAL LTD
|
|
|
|