CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of soft tissue grafts in anterior cruciate ligament reconstruction, Part Number: 014208
- Company
- Smith & Nephew, Inc.
- Recall Initiated
- April 8, 2021
- Terminated
- June 22, 2022
- Recall Number
- Z-1510-2021
- Quantity
- 2 units US and 193 units OUS. 195 units WW
- Firm Location
- Andover, MA
Reason for Recall
Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw
Distribution
Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Australia, Japan.
Lot / Code Info
Lot Number: 50906647
Root Cause
Process control
Action Taken
Smith & Nephew issued Urgent Medical Device Recall letter FSN on April 08, 2021via email and FedEx. Letter states reason for recall, health risk and action to take: 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.