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U.S. Department of Health and Human Services

Class 2 Device Recall ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM

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 Class 2 Device Recall ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEMsee related information
Date Initiated by FirmJanuary 06, 2009
Date PostedJuly 22, 2009
Recall Status1 Terminated 3 on June 25, 2012
Recall NumberZ-1371-2009
Recall Event ID 50901
510(K)NumberK023102 
Product Classification Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
ProductAccolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40 taper Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree neck angle. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.
Code Information 6021-3535 ACCOLADE (127 DEG) SIZE 3.5 24956202 6021-3535 ACCOLADE (127 DEG) SIZE 3.5 25025001 6021-3535 ACCOLADE (127 DEG) SIZE 3.5 25025003 6021-3535 ACCOLADE (127 DEG) SIZE 3.5 25025004 6021-3535 ACCOLADE (127 DEG) SIZE 3.5 25046901 6021-3535 ACCOLADE (127 DEG) SIZE 3.5 25080901 6021-3535 ACCOLADE (127 DEG) SIZE 3.5 25080902 6021-3535 ACCOLADE (127 DEG) SIZE 3.5 25095701 6021-3535 ACCOLADE (127 DEG) SIZE 3.5 25169903 6021-3535 ACCOLADE (127 DEG) SIZE 3.5 25190601 6021-3535 ACCOLADE (127 DEG) SIZE 3.5 25212102 6021-3535 ACCOLADE (127 DEG) SIZE 3.5 25232001 6021-3535 ACCOLADE (127 DEG) SIZE 3.5 25243801 6021-3535 ACCOLADE (127 DEG) SIZE 3.5 25256201 6021-3535 ACCOLADE (127 DEG) SIZE 3.5 25275701 6021-3535 ACCOLADE (127 DEG) SIZE 3.5 25275702 and 6021-3535 ACCOLADE (127 DEG) SIZE 3.5 25275703. 
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430
For Additional Information ContactColleen O'Meara
201-831-5000
Manufacturer Reason
for Recall		Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
FDA Determined
Cause 2		Process control
ActionAn "Urgent Product Recall" letter was sent via Federal Express on January 6, 2009 with return receipt to Stryker Branches/Agencies, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letter described the affected product, issue, potential hazards and risks. Stryker Branches and Hospital Risk Management were asked to examine their inventory for affected product. Stryker Representatives were instructed to contact customers to reconcile and return recalled product to Stryker Orthopaedics. All letters include a response form to be completed and returned indicating that they have been informed of the recall and the amount of product on hand, if any. Direct questions about the recall to Stryker Orthopaedics at 1-201-831-5718.
Quantity in Commerce1,628 total stems, all varieties.
DistributionNationwide Distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MEH
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