Z-3171-2024Class II

DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener

Name: Z-3171-2024 DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
Creator: Smith & Nephew, Inc.
Published: 2024-07-09
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2024-07-09 / Open, Classified / root cause: packaging

FDA source

Smith & Nephew, Inc. began a recall of DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener on 2024-07-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-3171-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-09
Posted: 2024-09-19
Recalling firm: Smith & Nephew, Inc.
Product: DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
Product code: HTY Pin, Fixation, Smooth
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.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: Smith & Nephew issued and Urgent Medical Device Recall Notice to its consignees on 07/09/2024 via overnight mail. The notice explained the problem, potential risk, and requested the return of the product. Sales representatives, District Offices, and/or Distributors were directed to notify their customers. For questions or concerns regarding this recall please contact [email protected].
Quantity in commerce: 24 units
Distribution: US, Canada, Norway
Product codes and lots: Batch 23GNX0077

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3171-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3171-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-19
Z-3172-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-19

Product code HTY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)