Z-2340-2010

Long Nail Kit R2.0, Ti RIGHT 011x360 mm x 125 degrees; Sterile, TI Alloy, Implant; Catalog number 3225-0360S...

Name: Z-2340-2010 Long Nail Kit R2.0, Ti RIGHT 011x360 mm x 125 degrees; Sterile, TI Alloy, Implant; Catalog number 3225-0360S...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2010-07-23
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2010-07-23 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Long Nail Kit R2.0, Ti RIGHT 011x360 mm x 125 degrees; Sterile, TI Alloy, Implant; Catalog number 3225-0360S. Stryker Trauma GmbH, 24232 Schenjrchen, Germany... on 2010-07-23. The reason FDA records is "The nail has no thread for the set screw hindering insertion". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2340-2010
Status: Terminated
Initiated: 2010-07-23
Posted: 2010-09-02
Terminated: 2012-08-06
Recalling firm: Howmedica Osteonics Corp
Product: Long Nail Kit R2.0, Ti RIGHT 011x360 mm x 125 degrees; Sterile, TI Alloy, Implant; Catalog number 3225-0360S. Stryker Trauma GmbH, 24232 Schenjrchen, Germany; distributed in USA by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430. Intended for temporary fixation, correction, or stabilization of the right femur.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: The nail has no thread for the set screw hindering insertion.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Urgent Product Recall letters were sent on July 23, 2010 by Federal Express to Stryker branches. A corrected letter was sent on July 26, 2010 to correct an error in the size of the screw. Additionally, letters were sent on July 26, 2010 to Hospital Risk Managers, Chief of Orthopaedics and Surgeons. The letter identified the affected product, explained the issue, discussed the potential hazard, and the risk mitigation. Customers are to examine their inventory, retrieve all affected product and return it; then reconcile all products on the Product Recall Acknowledgement Form and fax it back. Questions should be directed towards Richard Wolyn at 201-972-2100.
Quantity in commerce: 12 units
Distribution: Nationwide Distribution -- NJ, NY, DE, IN, WI, IL, PA and NM.
Product codes and lots: Lot code K248963; Expiration: 8/14/2014.

Product code HSB

K034002Class IIGamma3 Nail SystemHowmedica Osteonics Corp. / cleared 2004-01-15

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)