Advanced Cement Mixing Bio-Prep Cement Application Kit, Rx, Sterile, REF 306-563S10, 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.
FDA Recall Z-1106-2010 · Posted 2010-03-15
Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeGDY
Date Initiated2010-01-25
Date Terminated2010-10-25
Product Quantity9,274 all products.
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.
Firm 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
Root Cause
Other
Distribution Pattern
Worldwide Distribution -- United States, Canada, Mexico, Australia, Brazil, Switzerland, Japan, Netherlands, England, UK, Sweden, Hong Kong, Korea, Malaysia, Singapore, Argentina, Spain, and Italy.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.