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

Class 2 Device Recall JETX(R) STERILE DRILL

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


New Search Back to Search Results
 Class 2 Recall
JETX(R) STERILE DRILL
see related information
Date Posted June 06, 2012
Recall Status1 Open
Recall Number Z-1708-2012
Recall Event ID 61767
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product 4.8 MM X 1.8 MM DRILL FOR HA COATED HALF PINS, CANNULATED, REF 71070845, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
Code Information Lot Numbers: 11KNG0002, 4500043549, 466140H, 466140N, 466140P, 466140Q, 466140R, 469639-1A
Recalling Firm/
Manufacturer
Smith & Nephew Inc
1450 E. Brooks Rd
Memphis, Tennessee 38116
For Additional Information Contact Joe Metzger
978-749-1330
Manufacturer Reason
for Recall
Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging
Action Smith & Nephew Sales Representatives and Smith & Nephew International Distributors were notified of the problem with the affected product and the recall via email on April 13, 2012. All affected direct consignees were notified via Fed Ex on April 13, 2012. The Urgent Medical Device Recall letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease use and distribution of the product and quarantine them immediately for return. Customers were instructed to complete the Inventory Return Certification Form included with the letter. Customers should fax or email the form to 901-566-7975 or fieldactions@smith-nephew.com. The affected product should be returned to: Smith & Nephew Attn: Global Field Actions Safety Affairs 1450 Brooks Road Memphis, Tennessee 38116 If the affected product was distributed further customers were instructed to provide a copy of the recall letter to these customers.
Quantity in Commerce 44 units
Distribution Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
-
-