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 Restoration Modular Conical Distal Stem

  • 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 Restoration Modular Conical Distal Stem see related information
Date Initiated by Firm November 21, 2008
Date Posted January 26, 2009
Recall Status1 Terminated 3 on June 25, 2012
Recall Number Z-0884-2009
Recall Event ID 50498
510(K)Number K022549  
Product Classification prosthesis, hip - Product Code LZO
Product Restoration Modular Conical Distal Stem;
Sterile, Titanium Alloy. One unit per package.
Stryker Ireland
Carrigtwohill County Cork, Ireland.
Authorized Representative in Europe: Stryker France, Cedex France.
This system is intended to be used for primary or revision total hip arthroplasty, as well as in the presence of servere proximal bone loss.
Code Information Catalog No. 6276-7-017 (17mm), Lot Code CAXHA68D; Catalog No. 6276-7-014, (14mm) Lot Code CAXHB18A
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430
For Additional Information Contact Karen Ariemma, RAC
201-831-5718
Manufacturer Reason
for Recall		 Stryker became aware of a lot for lot mix up.
FDA Determined
Cause 2		 Labeling mix-ups
Action Recall notification letters sent via Federal Express on Nov. 21, 2008 to Branches/Agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeons. Letters explain the labeling mix up and the potential risks to patients if the wrong size stem is used. Stryker branches are asked to examine inventory and that of hospital locations to identify affected product. All affected product is to be reconciled on the Product Accountability form and the form faxed back to Stryker. Contact Stryker Howmedical Osteonics Corporation for additional information at 1-201-831-5718.
Quantity in Commerce 4
Distribution Class II Recall - Nationwide Distribution
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.
510(K) Database 510(K)s with Product Code = LZO and Original Applicant = HOWMEDICA OSTEONICS CORP.
-
-