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

Class 2 Device Recall Version 2 D8L OFFSET RASP HANDLE, RT

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


New Search Back to Search Results
 Class 2 Recall
Version 2 D8L OFFSET RASP HANDLE, RT
see related information
Date Posted August 14, 2014
Recall Status1 Open
Recall Number Z-2225-2014
Recall Event ID 68656
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product VER2 D8L OFFSET RASP HANDLE, RT Nonsterile
Code Information Item Number 82016761302 Lot Number 97009564, 97009565, 97009570
Recalling Firm/
Manufacturer
Zimmer, Inc.
1800 W Center St
Warsaw, Indiana 46580-2304
For Additional Information Contact Consumer Relations Call Center
800-447-5633
Manufacturer Reason
for Recall
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
FDA Determined
Cause 2
DESIGN: Device Design
Action On July 23, 2014, Zimmer issued recall notification to their consignees. Distributors were notified via electronic mail and courier. Recall notification included a description of the issue, affected product, possible risks to patient, and instructions for responding to the recall. Questions or concerns regarding the recall are directed to Zimmer customer call center @ 1-800-348-2759 M-F, 8am-8pm ET.
Quantity in Commerce 412 units
Distribution Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.
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.
-
-