TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.
This recall has been terminated (originally issued June 24, 2020).
- Company
- Smith & Nephew Inc
- Recall Initiated
- June 24, 2020
- Terminated
- April 28, 2021
- Recall Number
- Z-2685-2020
- Quantity
- 12 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
Reason for Recall
A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
Distribution
International distribution in the countries of Brazil, Colombia and United Arab Emirates.
Lot / Code Info
Model: 71655139 Lot: 19BM13592A
Root Cause
Reprocessing Controls
Action Taken
On 06/24/2020 the firm sent an email 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.