FDA recall Z-3172-2024

Smith & Nephew, Inc. · Class II · device

Product

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

US, Canada, Norway

Key facts

Status
Ongoing
Initiation date
2024-07-09
Report date
2024-09-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3172-2024