Recall Z-1510-2021 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
Smith & Nephew, Inc.
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
| Date | Apr 8, 2021 |
| Status | Terminated |
| Reason | Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw |
| Root cause | Process control |
| Action | 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, p |
| Quantity | 2 units US and 193 units OUS. 195 units WW |
| Distribution | Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Australia, Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K921481 | INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR Acufex Microsurgical, Inc., Aug 24, 1993 |