Z-3172-2024 Class II Ongoing
FDA device recall Z-3172-2024 was initiated by Smith & Nephew, Inc. on July 9, 2024 and is designated Class II. Reason for recall: Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT… The recall status is ongoing. Affected quantity: 73 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 25, 2024
- Initiation Date
- July 9, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 73 units
Product Description
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener
Reason for Recall
Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label.
Distribution Pattern
US, Canada, Norway
Code Information
Batch 21KNX0074