Recall archive / FDA device enforcement
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener — FDA record Z-3171-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 9, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
- 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.
- Classification
- Class II
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 24 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-3171-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Batch 23GNX0077 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US, Canada, Norway
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Sep 25, 2024
- Recall initiation date
- Jul 9, 2024
- Center classification date
- Sep 19, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.