Date Initiated by Firm | April 20, 2010 |
Date Posted | August 10, 2010 |
Recall Status1 |
Terminated 3 on January 19, 2011 |
Recall Number | Z-2204-2010 |
Recall Event ID |
55909 |
510(K)Number | K023546 |
Product Classification |
knee prosthesis - Product Code JWH
|
Product | Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, REF 183022, Knee prosthesis component. |
Code Information |
M402080. |
Recalling Firm/ Manufacturer |
Biomet, Inc. 56 E Bell Dr Warsaw IN 46582
|
For Additional Information Contact | 574-267-6639 Ext. 1676 |
Manufacturer Reason for Recall | A knee implant labeled as left was opened and the package actually contained a right knee implant. |
FDA Determined Cause 2 | Process control |
Action | On 4/13, 14 and 15 Biomet made phone calls to the consignees to inform them of the recall. The firm sent Urgent Medical Device Recall Notices dated 4/20/2010. The customers were instructed to immediately locate the recalled products and return them to the manufacturer. |
Quantity in Commerce | 5 |
Distribution | 1 unit in US. 3 units in Biomet distributor inventory, 1 unit in Japan |
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 = JWH
|