FDA-Device2024-09-25Class II

DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener

Smith & Nephew, Inc.
Hazard

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.

Sold states
US, Canada, Norway
Affected count
73 units
Manufactured in
1450 E Brooks Rd, Memphis, TN, United States
Products
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener

Official notice

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

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