Femoral Sponge 10 inches REF 206-715, Rx Sterile, Stryker Instruments Kalamazoo, MI. The femoral sponge is an absorbent
FDA device recall Z-1104-2010 · posted 2010-03-15 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Reason for recall
- The firm did not have packaging validation to support the labeled shelf life. There is potential for a breach in sterility specific to the sterile packaged femoral sponge which may result in a non-sterile product.
- Action taken
- A "Medical Device Recall Notification" dated January 21, 2010 was issued to customers. The notification described the affected product, issue and actions to take. Consignees were asked to forward the notification to all their affected locations. Customers were instructed to immediately check inventory and quarantine any recalled product found. Consignees were instructed to destroy all product and report how much product was destroyed. For questions regarding this recall, please contact Stryker Instruments by calling 1-800-800-4236, ext. 4354
- Root cause
- Other
- Status
- Terminated
- Product code
- GDY
- Quantity affected
- 9,257 all products
- Distribution
- Worldwide Distribution -- United States, Canada, Mexico, Australia, Brazil, Switzerland, Japan, Netherlands, England, UK, Sweden, Hong Kong, Korea, Malaysia, Singapore, Argentina, Spain, and Italy.
- Date initiated
- 2010-01-25
- Date posted
- 2010-03-15
- Date terminated
- 2010-10-25
- Location
- Kalamazoo, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE (K955599) | Stryker Corp. | 1996-02-22 |