FDA Device recall Z-1510-2021
CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of soft tissue grafts i…
- FDA Device
- Class II
- terminated
- Published 2021-05-05
On 2021-05-05 the FDA classified a Class II recall of CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of soft tissue grafts i… by Smith And Nephew, citing mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1510-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-08 |
| Published | 2021-05-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Smith And Nephew |
| Distribution | US |
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
Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw
Identifiers
| code_info | Lot Number: 50906647 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1510-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.