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U.S. Department of Health and Human Services

Class 2 Device Recall Femoral sponge.

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  Class 2 Device Recall Femoral sponge. see related information
Date Initiated by Firm January 25, 2010
Date Posted March 15, 2010
Recall Status1 Terminated 3 on October 25, 2010
Recall Number Z-1105-2010
Recall Event ID 54622
510(K)Number K955599  K9410605  
Product Classification Gauze/sponge, internal, x-ray detectable - Product Code GDY
Product Bio-Prep Bone Preparation Kit with Merocel sponge for use in total hip arthroplasty. REF 206-730, Rx, Sterile, 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.
Code Information 04230CE2, 04257CE2, 04286CE2, 04310CE2, 04334CE2, 05004CE2, 05041CE2, 05109CE2, 05200012, 05222012, 05292012, 05346012, 06038012, 06128012, 06172012, 06241012, 06268012, 06313012, 06348012, 07022012, 07031012, 07053012, 07081012, 07106012, 07136012, 07177012, 07192012, 07219012, 07253012, 07276012, 07320012, 07341012, 08010012, 08043012, 08063012, 08095012, 08127012, 08162012, 08177012, 08203012, 08249012, 08296012, 08325012, 08351012, 09040012, 09075012, 09106012 and 09138012.
Recalling Firm/
Stryker Instruments Div. of Stryker Corporation
4100 E. Milham Ave.
Kalamazoo MI 49001
For Additional Information Contact Angela Regainis
Manufacturer 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.
FDA Determined
Cause 2
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 in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GDY and Original Applicant = STRYKER CORP.