Recall Z-1510-2021— Smith & Nephew, Inc.
Class II · Terminated
Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2021-04-08, terminated 2022-06-22. It names one FDA 510(k) clearance: K921481. Product: 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. Reason: Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw.
- Recalling firm
- Smith & Nephew, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-08
- Terminated
- 2022-06-22
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw
Data sourced from openFDA. This site is unofficial and independent of the FDA.