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

Class 2 Device Recall Solar Shoulder Humeral Stem

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


New Search Back to Search Results
 Class 2 Recall
Solar Shoulder Humeral Stem
see related information
Date Posted January 26, 2009
Recall Status1 Terminated on January 20, 2010
Recall Number Z-0888-2009
Recall Event ID 50485
Premarket Notification
510(K) Numbers
K020989  K022555  K031744  K041170  K050741  K053514 
K070095  K070963  K932519  K941366  K955731  K982032 
K983226 
Product Classification Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented - Product Code KWS
Product Solar Shoulder Humeral Stem These devices are modular components of a total shoulder system. These humeral stems are intended for use with humeral heads and glenoid components in primary or revision total shoulder arthroplasty.
Code Information CAT. NO.5351-4103, SHOULDER - HUMERAL STEM 7mm , LOT CODE XKRMHE, CAT. NO. 5351-4105 SHOULDER - HUMERAL STEM 9mm, LOT CODE 8ETMJE, CAT. NO. 5351-4105 SHOULDER - HUMERAL STEM 9mm LOT CODE 8EYMJE, CAT. NO. 5351-4107 SHOULDER - HUMERAL STEM 11mm LOT CODE V45MKE, CAT. NO. 5351-4108 SHOULDER - HUMERAL STEM 12mm LOT CODE VV3MKE, CAT. NO. 5351-4108 SHOULDER - HUMERAL STEM 12mm LOT CODE VV4MKE, CAT. NO. 5351-4109 SHOULDER - HUMERAL STEM 13mm LOT CODE VWHMKE, CAT. NO. 5351-4110 SHOULDER - HUMERAL STEM 14mm LOT CODE HTXMKE, CAT. NO. 5351-4110 SHOULDER - HUMERAL STEM 14mm LOT CODE T7TMKE, CAT. NO. 5351-4113 SHOULDER - HUMERAL STEM 17mm LOT CODE KKHMKE and CAT. NO. 5351-4205 SHOULDER - HUMERAL 200mmX9mm LOT CODE MT9MKE
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 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
PRODUCTION CONTROLS: Packaging Process Control
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 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.
510(K) Database 510(K)s with Product Code = KWS and Original Applicant = HOWMEDICA OSTEONICS CORP
510(K)s with Product Code = KWS and Original Applicant = HOWMEDICA OSTEONICS CORP.
510(K)s with Product Code = KWS and Original Applicant = IND DIAGNOSTIC INC.
510(K)s with Product Code = KWS and Original Applicant = OSTEONICS CORP.
510(K)s with Product Code = KWS and Original Applicant = STRYKER ORTHOPAEDICS
-
-