|
Class 2 Device Recall Trabecular Metal acetabular Augments |
|
Date Initiated by Firm |
April 06, 2010 |
Date Posted |
August 12, 2010 |
Recall Status1 |
Terminated 3 on October 21, 2011 |
Recall Number |
Z-2214-2010 |
Recall Event ID |
55364 |
510(K)Number |
k061067
|
Product Classification |
prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
|
Product |
Trabecular Metal acetabular revision system buttress augment size, 54, 00-4898-001-54, sterile, Zimmer Inc., Parsippany, NJ.
Usage: Implantable devices that are used to address bony deficiencies of the pelvic antebulum in revision total hip arthroplasty surgery. |
Code Information |
60492194, 60531068, 60530835, 60724676, 60680532, 60770940, 60796676, 60904592, 61195210, 61076505, 61424513 and 61424514. |
Recalling Firm/ Manufacturer |
Zimmer Inc. 345 E Main St Warsaw IN 46580-2746
|
For Additional Information Contact |
574-267-6131
|
Manufacturer Reason for Recall |
The firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.
|
FDA Determined Cause 2 |
Packaging |
Action |
The firm sent an "Urgent Device Removal" letter dated 4/6/2010. The consignees were instructed to inventory the products on hand and return the recalled product to the manufacturer. More information is available at 1-800-613-6131. |
Quantity in Commerce |
1972 all products |
Distribution |
US, Germany, Brazil, Singapore, Canada, Australia, England, India, and Switzerland. |
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 = LPH and Original Applicant = ZIMMER TRABECULAR
|
|
|
|