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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 FirmJanuary 25, 2010
Date PostedMarch 15, 2010
Recall Status1 Terminated 3 on October 25, 2010
Recall NumberZ-1108-2010
Recall Event ID 54622
510(K)NumberK955599 
Product Classification Gauze/sponge, internal, x-ray detectable - Product Code GDY
ProductACM 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.
Code Information 05257012 and 08129012.
Recalling Firm/
Manufacturer
Stryker Instruments Div. of Stryker Corporation
4100 E. Milham Ave.
Kalamazoo MI 49001
For Additional Information ContactAngela Regainis
269-323-7700
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
Other
ActionA "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 Commerce9,274 all products
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = GDY
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