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Recall Observatory FDA recall evidence

Device product

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

Z-3172-2024

July 09, 2024

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 95154
Status
Ongoing
Classification
Class II
Quantity
73 units
Official record key
device-enforcement:Z-3172-2024

Official wording

Reason: 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.

Code information: Batch 21KNX0074

Distribution pattern: US, Canada, Norway

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    packaging error