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.
What this means for you
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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