|Date Initiated by Firm
||October 25, 2013
|Date Posting Updated
||December 07, 2013
||Terminated 3 on March 31, 2015
|Recall Event ID
||Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
||1) Accolade II 127 Neck Angle Hip Stem, Size # 3
2) Accolade II 127 Neck Angle Hip Stem, Size #5
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 USA
Telephone # +1 201-831-5000
ZAC Satolas Green Pusignan
Av de Satolas Green
69881 MEYZIEU Cedex France
Intended for cementless application in total or hemiarthroplasty procedures.
Accolade II I27 Neck Angle Hip Stem, Size # 3, Catalog No.# 6721-0330 Lot Code #44416307
Accolade II 127 Neck Angle Hip Stem, Size #5, Catalog No. # 6721-0535 Lot Code 44564405
| Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
|For Additional Information Contact
||Ms. Christie Samsa
|Stryker received a report from the field indicating that an Accolade II Hip Stem Size #3 was identified in packaging with an Accolade II Hip Stem Size #5.
|Packaging process control
||Stryker sent an e-mail to their domestic locations on 10/11/2013. Notification letters and product accountability forms were sent via Fed Ex on 10/25/2013 with return receipt to branches/agencies and hospital risk management, chief of orthopaedics and surgeons.
|Quantity in Commerce
||Nationwide Distribution including states: AL, GA, IL, and WA.
|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)s with Product Code = JDI and Original Applicant = HOWMEDICA OSTEONICS