Z-1510-2021 Class II Terminated
FDA device recall Z-1510-2021 was initiated by Smith & Nephew, Inc. on April 8, 2021 and is designated Class II. Reason for recall: Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw The recall status is terminated (terminated June 22, 2022). Affected quantity: 2 units US and 193 units OUS. 195 units WW.
Recall Details
- Product Type
- Devices
- Report Date
- May 5, 2021
- Initiation Date
- April 8, 2021
- Termination Date
- June 22, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units US and 193 units OUS. 195 units WW
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
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Australia, Japan.
Code Information
Lot Number: 50906647