Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Navigator System Surgical kit (SGKIT),

  • 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 Navigator System Surgical kit (SGKIT),see related information
Date Initiated by FirmMay 09, 2008
Date PostedSeptember 16, 2008
Recall Status1 Terminated 3 on January 15, 2009
Recall NumberZ-2199-2008
Recall Event ID 48677
Product Classification Kit - Product Code EJB
ProductNavigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit SGDPH1 through SGDPH5. The product is used for CT guided surgery.
Code Information Kit Lots# 790554, 790555, 807340, 799305, 807340, 790082, and 808640.
FEI Number 1038806
Recalling Firm/
Manufacturer		 Biomet 3i, Inc.
4555 Riverside Drive
Palm Beach Gardens FL 33410
For Additional Information ContactEdward G. Sabin
561-776-6706
Manufacturer Reason
for Recall		The drill malfunctions while in use. The drill has been observed to become lodged in the handle.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe recall was initiated in 5/9/2008. Each US customer was contacted by telephone using a prepared phone script. Following telephone contact, Biomet 3i performed a follow-up of each call with a fax letter. International customers were first contacted by E-mail then by fax letter. Each customer was instructed to check their respective inventory for the affected product and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory. They were also instructed to return the affect product to Biomet 3I. Replacement handles will be provided. Contact Biomet 3i, at 1-561-776-6906 or x6904 for assistance.
DistributionWorldwide.
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.
-
-