Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7R, Catalog No.: 71-4107R, Lot Code: K05L310; Scorpio Tota
FDA device recall Z-1814-2008 · posted 2008-09-11 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Mislabeled boxes -- Scorpio PS Right Femoral Component No Posts contained a Scorpio PS Left Femoral Component with Posts and vice versa.
- Action taken
- Consignees were notified by letter sent via Federal Express with return receipt on November 8, 2005. All consginees who received the subject devices were provided Product Accountability forms to be returned to the firm.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- KWY
- Quantity affected
- 8 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2005-11-08
- Date posted
- 2008-09-11
- Date terminated
- 2010-05-13
- Location
- Mahwah, NJ
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM (K962152) | Osteonics Corp. | 1996-08-14 |