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.
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 3/5 (High).
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.
- Affected units
- 24
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.
Part of a larger recall action
This product is one of 2 recalled by Smith & Nephew, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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