DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener
FDA Recall #Z-3172-2024 — Class II — July 9, 2024
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.
Recalling Firm
Smith & Nephew, Inc. — Memphis, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
73 units
Distribution
US, Canada, Norway
Code Information
Batch 21KNX0074
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated