—#85928

Product

Scorpio NRG Posterior Stabilized Femoral, #3 Left; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K030978
Affected lot / code info: Catalog Number 81-4403L, Lot number MHEJ9R.

Why it was recalled

It was determined that a change made in the dimensions of the collar component of the packaging resulted in the inner blister material being overstretched causing a potential hole in the sterile barrier system.

Root cause (FDA determination)

Other

Action the firm took

An "Urgent Product Recall" letter was sent on October 2, 2009 by Federal Express to Stryker branches and Hospital Risk Management Departments in the United States as well as foreign consignees. The letter described the issue, potential hazard and actions for affected accounts. Consignees were instructed to examine their inventory and return recalled product as instructed in the notification letter to Stryker Orthopaedics. In addition, consignees were instructed to reconcile affected product by completing the attached Product Accountability form (with spreadsheet) and faxing to 1-201-831-6069. Direct questions to Stryker Orthopaedics by calling 1-201-972-2100.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- United States (MA, NJ, IN, MI, CA and PA), Hong Kong, Germany, Netherlands, Japan, Korea, Switzerland, Malaysia, and the United Kingdom.

Timeline

Recall initiated: 2009-10-02
Posted by FDA: 2009-12-01
Terminated: 2010-04-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85928. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.