Date Initiated by Firm |
September 04, 2009 |
Date Posted |
November 23, 2009 |
Recall Status1 |
Terminated 3 on June 26, 2013 |
Recall Number |
Z-0390-2010 |
Recall Event ID |
53434 |
510(K)Number |
K010757 K993601 K022077 K061434
|
Product Classification |
hip prosthesis component. - Product Code JDG
|
Product |
Stryker Howmedica Osteonics, Skirted 5 40' Taper V40 Femoral Head (26 mm +8mm offset), hip prosthesis component.
|
Code Information |
Catalog number 6260-5-326; Lot code 29018201 |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Drive Mahwah NJ 07430
|
For Additional Information Contact |
RIchard Wolyn 201-831-5158
|
Manufacturer Reason for Recall |
Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head.
|
FDA Determined Cause 2 |
Process control |
Action |
Stryker sent Notification letters and Product Accountability Forms via FedEx on September 4, 2009 with return receipt. Corrected letters were sent on September 9, 2009. |
Quantity in Commerce |
7 units |
Distribution |
Nationwide distribution. |
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.
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510(K) Database |
510(K)s with Product Code = JDG and Original Applicant = HOWMEDICA OSTEONICS CORP 510(K)s with Product Code = JDG and Original Applicant = HOWMEDICA OSTEONICS CORP.
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