Date Initiated by Firm |
November 13, 2008 |
Date Posted |
January 26, 2009 |
Recall Status1 |
Terminated 3 on January 20, 2010 |
Recall Number |
Z-0901-2009 |
Recall Event ID |
50485 |
510(K)Number |
K070963
|
Product Classification |
prosthesis, shoulder - Product Code HSD
|
Product |
Reunion HA Fracture Stem
These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. |
Code Information |
R5351-4507 REUNION HA FRACTURE STEM 7MM T2T72836-J, R5351-4508 ReUnion HA Fracture Stem 8MM T2N71522-I, R5351-4508 ReUnion HA Fracture Stem 8MM T2T72422-C and R5351-4509 REUNION HA FRACTURE STEM 9MM T2N71523-G |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430
|
For Additional Information Contact |
Karen Ariemma, RAC 201-831-5000
|
Manufacturer Reason for Recall |
Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.
|
FDA Determined Cause 2 |
Packaging |
Action |
Recall notification letters were sent via Federal Express on November 21, 2008 to Stryker Branches/Agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeon. The letters explained the problem and indicated that there are no risk factors. Contact Stryker Orthopaedics for additional information at 1-201-831-5718. |
Quantity in Commerce |
322 total units - all types |
Distribution |
Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden. |
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 = HSD and Original Applicant = HOWMEDICA OSTEONICS CORP
|