—#88800

Product

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 product code: GDY — Gauze/Sponge, Internal, X-Ray Detectable
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K955599
Affected lot / code info: 06292012, 07297012, 07354012 and 08164012.

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E. Milham Ave., Kalamazoo, Michigan 49001

Distribution

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.

Timeline

Recall initiated: 2010-01-25
Posted by FDA: 2010-03-15
Terminated: 2010-10-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #88800. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.