| Class 2 Device Recall TRIGEN INTERTAN | |
Date Initiated by Firm | November 02, 2020 |
Create Date | January 06, 2021 |
Recall Status1 |
Terminated 3 on January 06, 2023 |
Recall Number | Z-0772-2021 |
Recall Event ID |
86927 |
510(K)Number | K040212 |
Product Classification |
Nail, fixation, bone - Product Code JDS
|
Product | Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fracture; |
Code Information |
Model #: 71675535 & 71675532 Lot #: 20CM25278 & 20DM01466. |
Recalling Firm/ Manufacturer |
Smith & Nephew, Inc. 1450 E Brooks Rd Memphis TN 38116-1804
|
For Additional Information Contact | Garry Smith 901-396-2121 |
Manufacturer Reason for Recall | Manufacturing packaging error. |
FDA Determined Cause 2 | Packaging process control |
Action | On 11/02/2020 the firm send a letter to its consignees with the following instructions:
Required Actions:
1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately.
a. If you are a sales rep or distributor, you must notify your customers of the field action and ensure that the required actions are complete.
b. Include the customers account number and name in the table below.
2. If you have no product to return, please put an X in the appropriate location below.
3. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes below.
4. Complete the remainder of the form, sign and send to FieldActions@smith-nephew.com.
Please Note even if you have no product to return, this form must be completed, signed and returned.
5. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number.
If you have any questions or concerns regarding this recall please contact FieldActions@smith-nephew.com. |
Quantity in Commerce | 41 units |
Distribution | Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, FL, IA, KY, MI, NC, NJ, OH, PA, TN, TX, WA and the countries of AU, CA & GB. |
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 = JDS
|
|
|
|