Smith & Nephew Recalls Mislabeled CANNU-Flex SILK Interference Screws
Smith & Nephew is recalling CANNU-Flex SILK Interference Screws because some boxes were mislabeled, containing 6mm x 20mm screws instead of the labeled 6mm x 30mm size.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is a labeling error leading to potential use of the wrong device size, which fits the criteria for moderate severity without reported injuries.
Plain-English summary
Smith & Nephew, Inc. is recalling CANNU-Flex SILK Interference Screws, Part Number 014208. These medical devices are used for interference fixation of bone-tendon-bone or soft tissue grafts in anterior cruciate ligament reconstruction.
The recall is due to a labeling error where a box labeled for 6mm x 30mm screws actually contained a 6mm x 20mm screw. This discrepancy could lead to the use of an incorrect device size during surgery.
A total of 195 units are affected, with 2 units distributed in the United States (specifically Florida) and 193 units distributed overseas in Australia and Japan. Healthcare providers and patients should check their inventory and contact Smith & Nephew for further instructions.
The recalled product
- 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
- Manufacturer
- Smith & Nephew, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 50906647
Distribution
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