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U.S. Department of Health and Human Services

Class 2 Device Recall Solar PureFix HA Soulder Humeral Stem

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  Class 2 Device Recall Solar PureFix HA Soulder Humeral Stem see related information
Date Initiated by Firm November 15, 2007
Date Posted June 26, 2008
Recall Status1 Terminated 3 on January 25, 2010
Recall Number Z-1236-2008
Recall Event ID 45946
510(K)Number K061677  
Product Classification Shoulder Prosthesis - Product Code KWS
Product Solar HA Humeral Stem with Plasma Coating 7mm to 17 mm Product Catalog Number: 5351-4307 to 5351-4317. For use as a Shoulder Replacement. Stryker Orthopaedics Made in USA
Code Information All Lot Codes for the following: Catalog # 5351-4307, 7mm; 5351-4308, 8mm; 5351-4309, 9mm; 5351-4310, 10mm; 5351-4311, 11mm; 5351-4312, 12mm; 5351-4313, 13mm; 5351-4314, 14mm; 5351-4315, 15mm; 5351-4316, 16mm; and 5351-4317, 17mm.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Rose Mincieli
201-831-6633
Manufacturer Reason
for Recall		 Delamination: Loosening of the titanium plasma coating on the product was observed on twelve non-distributed units.
FDA Determined
Cause 2		 Process control
Action On 11/28/2007, Stryker Orthopaedics sent, via FedEx, Urgent Product Recall notification letters to distributors, hospitals, surgeons and hospitals' Chiefs of Orthopaedics informing them of the firm's voluntary recall of the affected product. They were instructed to discontinue use of the product and to have the units returned to the firm. Distributors were further instructed to notify their customers using the sub-recall letter provided by the firm. The letter to surgeons also informed them to monitor their patients who had received an implant of the product.
Quantity in Commerce 915 units
Distribution Nationwide - USA
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 = KWS and Original Applicant = HOWMEDICA OSTEONICS CORP
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