CANNU-Flex SILK Interference Screws 6 mmx 30 mm — Class II medical device recall Z-1510-2021
Terminated recall by Smith & Nephew, Inc., reported 2021-05-05, distributed nationwide. Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw
| Recall number | Z-1510-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Andover, MA, United States |
| Recall initiated | 2021-04-08 |
| Classified | 2021-04-29 |
| Reported by FDA | 2021-05-05 |
| Terminated | 2022-06-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, JP |
| Reason classes | labeling |
| Lot numbers | 50906647 |
| Model numbers | 014208 |
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 for recall
Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1510-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.