Device product
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
Z-3171-2024
Product summary
- Event
- Event 95154
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 24 units
- Official record key
device-enforcement:Z-3171-2024
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 23GNX0077
Distribution pattern: US, Canada, Norway
Derived failure modes
-
Labeling or packaging
packaging error