Date Initiated by Firm |
October 23, 2012 |
Date Posted |
January 08, 2013 |
Recall Status1 |
Terminated 3 on September 11, 2013 |
Recall Number |
Z-0656-2013 |
Recall Event ID |
61718 |
510(K)Number |
K994366
|
Product Classification |
Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
|
Product |
Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint. |
Code Information |
Catalog Number: 6021-2530 Lot #40264005 Catalog Number: 6021-3535 Lot #40163005. This lot was not received in the US. |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Drive Mahwah NJ 07430
|
For Additional Information Contact |
Ms. Colleen O'Meara 201-972-2100
|
Manufacturer Reason for Recall |
Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix.
|
FDA Determined Cause 2 |
Labeling mix-ups |
Action |
Stryker sent "Urgent Medical Device Recall Notification" letters and product accountability forms via Fed Ex with return receipt on 10/23/12 to branches/agencies and to hospitals and physicians on 10/24/12. The letter described the issue and provided recommended actions to mitigate the risk. Customers can call (201) 972-2100 if questions. |
Quantity in Commerce |
6021-2530- four units; 6021-3535- |
Distribution |
Nationwide distribution, including the states of NY, NJ, CA and FL. |
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 = MEH and Original Applicant = HOWMEDICA OSTEONICS CORP.
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