Recall Z-1108-2010 ยท GDY Gauze/Sponge, Internal, X-Ray Detectable
Stryker Instruments Div. of Stryker Corporation
ACM Bio-Prep with Merocel pkg/6, Rx, Sterile, REF 0306-708-000S4, Stryker Instruments, Kalamazoo, MI. The femoral sponge is an absorbent that is used to dry the intramedullary canal prior to the application of bone cement. The suction effectively absorbs blood and fluid from the canal. It may provide swabbing/scrubbing action during suction.
| Date | Mar 15, 2010 (initiated Jan 25, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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 |
| Quantity | 9,274 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955599 | STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE Stryker Corp., Feb 22, 1996 |