FDA-Device2021-05-05Class II
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
Smith & Nephew, Inc.
Hazard
Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw
Sold states
Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Australia, Japan.
Affected count
2 units US and 193 units OUS. 195 units WW
Manufactured in
150 Minuteman Rd, N/A, Andover, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1510-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief