K-Wire Packaging Error Recall by Smith & Nephew
Smith & Nephew issued a voluntary recall of K-Wire bone fixation fasteners due to a packaging error where packages contained the wrong wire diameter than labeled.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a risk-of-harm medical device where the wrong diameter bone fixation wire could compromise surgical fixation. No injuries or illnesses have been reported, placing this in the theoretical risk category.
Plain-English summary
Smith & Nephew, Inc. has initiated a voluntary field action to remove K-Wire bone fixation fasteners (Reference 128042) from the field. A packaging error resulted in at least one package containing K-WIRE .062X9 2PT DM wires instead of the labeled K-WIRE .045X9 2PT DM specification.
The recalled batch is 23GNX0077. The products were distributed in the United States, Canada, and Norway. A total of 24 units are affected by this recall.
K-Wires are metallic bone fixation devices used in surgical procedures. The use of an incorrect wire diameter could result in improper bone fixation during surgery. Customers who received products from this batch should verify the actual contents against the package label. If a mismatch is found, the product should not be used and the manufacturer should be contacted.
The recalled product
- Product
- DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- mislabeling
- product-substitution
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)
- Batch 23GNX0077
Distribution
Distribution scope not specified by the agency.
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