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  Class 2 Device Recall ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM see related information
Date Initiated by Firm January 06, 2009
Date Posted July 22, 2009
Recall Status1 Terminated 3 on June 25, 2012
Recall Number Z-1372-2009
Recall Event ID 50901
510(K)Number K023102  
Product Classification Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
Product Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray;
V40 taper
Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree neck angle.

Code Information 6021-4535 ACCOLADE (127 DEG) SIZE 4.5 24956301 6021-4535 ACCOLADE (127 DEG) SIZE 4.5 24973501 6021-4535 ACCOLADE (127 DEG) SIZE 4.5 25025502 6021-4535 ACCOLADE (127 DEG) SIZE 4.5 25025503 6021-4535 ACCOLADE (127 DEG) SIZE 4.5 25109103 6021-4535 ACCOLADE (127 DEG) SIZE 4.5 25169701 6021-4535 ACCOLADE (127 DEG) SIZE 4.5 25190701 6021-4535 ACCOLADE (127 DEG) SIZE 4.5 25244401 6021-4535 ACCOLADE (127 DEG) SIZE 4.5 25338602 6021-4535 ACCOLADE (127 DEG) SIZE 4.5 25372501  6021-4535 ACCOLADE (127 DEG) SIZE 4.5 25427901and 6021-4535 ACCOLADE (127 DEG) SIZE 4.5 25445501.  
Recalling Firm/
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430
For Additional Information Contact Colleen O'Meara
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
Action An "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 Commerce 1,628 total stems, all varieties.
Distribution Nationwide Distribution.
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 = MEH and Original Applicant = HOWMEDICA OSTEONICS CORP.