Date Initiated by Firm |
October 25, 2013 |
Date Posted |
December 07, 2013 |
Recall Status1 |
Terminated 3 on March 31, 2015 |
Recall Number |
Z-0467-2014 |
Recall Event ID |
66761 |
510(K)Number |
K120578
|
Product Classification |
Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
|
Product |
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
Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France
Intended for cementless application in total or hemiarthroplasty procedures. |
Code Information |
510K K120578 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 |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2002
|
For Additional Information Contact |
Ms. Christie Samsa 201-831-6365
|
Manufacturer Reason for Recall |
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.
|
FDA Determined Cause 2 |
Packaging process control |
Action |
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 |
20 units |
Distribution |
Nationwide Distribution including states: AL, GA, IL, and WA. |
Total Product Life Cycle |
TPLC Device Report
|
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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 = JDI and Original Applicant = HOWMEDICA OSTEONICS
|