Scorpio PS Basic Femur; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are
FDA device recall Z-0468-2010 · posted 2009-12-01 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 77 of total product
- Distribution
- Worldwide Distribution -- United States (MA, NJ, IN, MI, CA and PA), Hong Kong, Germany, Netherlands, Japan, Korea, Switzerland, Malaysia, and the United Kingdom.
- Date initiated
- 2009-10-02
- Date posted
- 2009-12-01
- Date terminated
- 2010-04-05
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM (K974556) | Osteonics Corp. | 1998-02-27 |