| Class 2 Device Recall 7, 9, and 11Hole VL Gridlock Fibula Plating System | |
Date Initiated by Firm | August 06, 2015 |
Date Posted | August 31, 2015 |
Recall Status1 |
Terminated 3 on January 26, 2017 |
Recall Number | Z-2490-2015 |
Recall Event ID |
71967 |
510(K)Number | K121452 |
Product Classification |
Plate, fixation, bone - Product Code HRS
|
Product | 7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-STERILE SINGLE USE ONLY; 11 Hole VL Gridlock Fibula Plate, Part # 300-60-003 NON-STERILE SINGLE USE ONLY. For use in trauma and reconstructive procedures in small bones. |
Code Information |
Lots: TSL002595, TSL002596, TSL002597 |
Recalling Firm/ Manufacturer |
Trilliant Surgical Ltd. 6721 Portwest Dr Ste 160 Houston TX 77024-8019
|
For Additional Information Contact | Customer Service 800-495-2919 |
Manufacturer Reason for Recall | The affected parts subject to the recall are out of specification, resulting in in the loss of the optimal locking screw functionality of the plates. The thread depth of the screw holes is insufficient, potentially limiting the ability to engage and lock with associated mating locking screws. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Trilliant Surgical sent an Urgent Medical Device Recall letter dated August 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The letter instructed and confirmed consignees to discontinue use of the affected lots, quarantine, and return product (if not yet done so) in accordance with an included acknowledgement sheet. For further questions, please call 1(800) 495-2919 , 8:00am - 5:00pm CST |
Quantity in Commerce | 28 units |
Distribution | US Distribution to the states of : FL, OH, NJ, MN, WI, NM and CA. |
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 = HRS
|
|
|
|