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

  • 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 see related information
Date Initiated by Firm October 27, 2004
Date Posted January 12, 2005
Recall Status1 Terminated 3 on December 20, 2005
Recall Number Z-0389-05
Recall Event ID 30476
Product Classification Tourniquet, Pneumatic - Product Code KCY
Product Zimmer™ Orthopaedic Surgical Products, Disposable Cuff, 12'' (30cm), Single Port, Single Bladder Sterile, Zimmer, Dover, OH USA. The cuff is a sterile, single use product equipped with an integral fill line. The product is packed 10 cuffs per unit
Code Information Cat #60-7075-002-00, Lot #60153745
Recalling Firm/
Manufacturer		 Zimmer Orthopaedic Surgical Products
2021 Old Mountain Rd
Statesville NC 28625-1630
For Additional Information Contact Joyce Elkins
330-364-9483
Manufacturer Reason
for Recall		 The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.
FDA Determined
Cause 2		 Other
Action Consignees were first notified via certified mail on 10/27/2004. A follow up letter with 2 addtional lots were sent 11/11/2004.
Quantity in Commerce 42 units (10 cuffs per unit)
Distribution Nationwide, Australia, Demark, Germany
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.
-
-