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U.S. Department of Health and Human Services

Class 2 Device Recall ReUnion

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  Class 2 Device Recall ReUnion see related information
Date Initiated by Firm May 09, 2007
Date Posted November 01, 2007
Recall Status1 Terminated 3 on March 07, 2008
Recall Number Z-0080-2008
Recall Event ID 38775
510(K)Number K062113  
Product Classification Shoulder prosthesis - Product Code KWS
Product ReUnion Fracture Stem Humeral Component - PureFix HA; Shoulder prosthesis.
Distal Diameter - 7 to 15mm;
Hydroxylapatite coated;
Titanium Plasma Spray;
Howmedica Osteonics Corp.
Code Information Product No. 5351-4507 to 5351-4515; 5351-4608. 5351-4610 and 5351-4612. All lot codes.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Larry Ross
201-831-5972
Manufacturer Reason
for Recall		 The plasma spray may delaminate from the proximal portion of the humeral stem.
FDA Determined
Cause 2		 Process control
Action Market Withdrawal letters were sent on May 9, 2007 via Federal Express. Letters to implanting physicians will be mail on or about mailed November 1, 2007. Stryker is also reissuing original letters indicating that this action is a Recall and advising of possible health hazards.
Quantity in Commerce 232 units
Distribution One hospital in Akron OH and 12 Stryker branches/agencies
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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