Class II — Smith & Nephew, Inc.
| Recalling firm | Smith & Nephew, Inc. |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw |
| 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 |
| 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. |
| Initiated | 2021-04-08 |
| Classified | 2021-04-29 |
| Terminated | 2022-06-22 |
| Recall number | Z-1510-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Smith & Nephew, Inc. (Z-1510-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87717/
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