Smith & Nephew K-Wire Surgical Device Recall for Packaging Error
Smith & Nephew is recalling K-Wire surgical devices due to a packaging error that resulted in wrong-sized wires being distributed. Healthcare providers may have received incorrectly sized bone fixation fasteners affecting approximately 73 units.
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 recall involves a risk-of-harm medical device where a packaging error could result in the use of wrong-sized surgical implants during orthopedic procedures. No injuries or adverse events have been reported to date, meeting the High severity criterion for risk-of-harm products without reported injury.
Plain-English summary
Smith & Nephew, Inc. is voluntarily recalling DIAMOND POINT K-WIRES (REF 128062), which are metallic bone fixation fasteners used in orthopedic surgical procedures. A packaging error resulted in incorrect product being distributed across two batches, including batch 21KNX0074. Packages labeled as K-WIRE .045X9 2PT DM were found to contain K-WIRE .062X9 2PT DM, which is a different diameter wire. The issue was discovered through a customer complaint.
Approximately 73 units of the incorrectly packaged K-Wires were distributed in the United States, Canada, and Norway. Surgeons or healthcare facilities that received this product may have had wires of the wrong diameter for their intended surgical procedures.
Customers who received product from the affected batches should not use the device and should contact Smith & Nephew to verify they received the correct product or to request a replacement. Healthcare providers should check their inventory for batch 21KNX0074 and similar shipments, and discontinue use if found.
No injuries or adverse events have been reported in connection with this recall at this time.
The recalled product
- Product
- DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 73
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 21KNX0074
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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