—#93304

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.

FDA product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K034002
Affected lot / code info: Lot code K248963; Expiration: 8/14/2014.

Why it was recalled

The nail has no thread for the set screw hindering insertion.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Drive, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Nationwide Distribution -- NJ, NY, DE, IN, WI, IL, PA and NM.

Timeline

Recall initiated: 2010-07-23
Posted by FDA: 2010-09-02
Terminated: 2012-08-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93304. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.