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 Reamer THandle

  • 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 Reamer THandle see related information
Date Initiated by Firm August 08, 2005
Date Posted February 17, 2010
Recall Status1 Terminated 3 on February 18, 2010
Recall Number Z-0793-2010
Recall Event ID 50099
Product Classification Orthopedic manual surgical instrument - Product Code HTO
Product Reamer T-Handle; Non- Sterile; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430.

Intended for use in orthopaedic surgery to interface with various cutting instruments and drivers.
Code Information Catalog Number: 1101-2100; Lot Codes: SZK01, SZK02, SZK03, SZK06 and SZL01.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
For Additional Information Contact Rita Intorella
201-972-2100
Manufacturer Reason
for Recall		 Stryker Orthopaedics learned that the T-handles have the potential to not engage and not attach to the reamer properly.
FDA Determined
Cause 2		 Device Design
Action Stryker Orthopaedics issued notification dated August 8, 2005 via Federal Express. Consignees were informed of the affected product and necessary steps to take for product replacement. For further information, contact Stryker at (201) 831-5825.
Quantity in Commerce 273
Distribution Worldwide Distribution -- United States, Germany, The Netherlands, Spain, Italy, Switzerland, Poland, Romania, South Africa, England, Columbia, Venezuela, Japan and Australia.
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.
-
-