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
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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.
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