| Class 2 Device Recall Solar Shoulder Humeral Stem | |
Date Initiated by Firm | November 13, 2008 |
Date Posted | January 26, 2009 |
Recall Status1 |
Terminated 3 on January 20, 2010 |
Recall Number | Z-0888-2009 |
Recall Event ID |
50485 |
510(K)Number | K955731 |
Product Classification |
prosthesis, shoulder - Product Code KWS
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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 NJ 07430
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = KWS
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