FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: 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.
- Recall number
- Z-2340-2010
- Recalling firm
- Stryker 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.
- Status
- Terminated
- Initiated
- 2010-07-23
- Posted
- 2010-09-02
- Terminated
- 2012-08-06
- Reason
- The nail has no thread for the set screw hindering insertion.
- 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
- 12 units
- Distribution
- Nationwide Distribution -- NJ, NY, DE, IN, WI, IL, PA and NM.
- Lot, serial or model codes
- Lot code K248963; Expiration: 8/14/2014.
- 510(k) numbers
- ["K034002"]
- PMA numbers
- not on file
- Product code
- HSB
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28