• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall TPS Bur

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall TPS Bur see related information
Date Initiated by Firm January 10, 2008
Date Posted April 22, 2008
Recall Status1 Terminated 3 on December 01, 2009
Recall Number Z-1015-2008
Recall Event ID 46341
510(K)Number K032303  
Product Classification bone cutting tool - Product Code HBE
Product Stryker 6.0 mm Barrel Bur, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-17-60.
Code Information All lots.
Recalling Firm/
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
Action Stryker 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 Commerce 10,588 of all products
Distribution Worldwide 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 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 = HBE and Original Applicant = STRYKER INSTRUMENTS