Date Initiated by Firm |
February 23, 2004 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on April 13, 2004 |
Recall Number |
Z-0777-04 |
Recall Event ID |
28433 |
510(K)Number |
K002998
|
Product Classification |
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented - Product Code KWT
|
Product |
Biomet brand Absolute Bi-Polar Shoulder Shell 48 mm w/locking ring; part 113156. |
Code Information |
lot 551440. |
Recalling Firm/ Manufacturer |
Biomet, Inc. 56 E Bell Dr Warsaw IN 46582-6989
|
For Additional Information Contact |
Paula Hoesel 800-348-9500 Ext. 1305
|
Manufacturer Reason for Recall |
The locking ring was not included and the shoulder implanted without the locking ring.
|
FDA Determined Cause 2 |
Other |
Action |
The firm recovered the consigneed units from hospital stocks and issued a letter dated 2/23/04 to the two implanting physicians. |
Quantity in Commerce |
7 |
Distribution |
California, Florida, Washington, Germany and Venezuela. |
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 = KWT and Original Applicant = BIOMET, INC.
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