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U.S. Department of Health and Human Services

Class 2 Device Recall TPS Drum

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 Class 2 Device Recall TPS Drumsee related information
Date Initiated by FirmJanuary 10, 2008
Date PostedApril 22, 2008
Recall Status1 Terminated 3 on December 01, 2009
Recall NumberZ-1020-2008
Recall Event ID 46341
510(K)NumberK032303 
Product Classification bone cutting tool - Product Code HBE
ProductStryker 7.8mm x 7.9mm Fluted Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-20-775.
Code Information All lots.
Recalling Firm/
Manufacturer
Stryker Instruments Div. of Stryker Corporation
4100 E. Milham Ave.
Portage MI 49002-9704
For Additional Information Contact
800-800-4236 Ext. 4056
Manufacturer Reason
for Recall
Lack of assurance of sterility.
FDA Determined
Cause 2
Package design/selection
ActionStryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
Quantity in Commerce10,588 of all products
DistributionWorldwide Distribution - USA, Australia, Brazil, Canada, England, France, Germany, Hong Kong, India, Italy, Japan, Mexico, the Netherlands, New Zealand, Portugal, Saudi Arabia, Poland, Romania, South Africa, Spain, Sweden, Switzerland and United Arab Emirates.
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 = HBE
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