| Class 2 Device Recall Biomet RINGLOC Instrumentation Impactor Plate | |
Date Initiated by Firm | October 18, 2007 |
Date Posted | February 05, 2008 |
Recall Status1 |
Terminated 3 on March 11, 2008 |
Recall Number | Z-0705-2008 |
Recall Event ID |
45987 |
Product Classification |
Acetabular Inserter Instrument - Product Code LXH
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Product | Biomet RINGLOC + Instrumentation Impactor Plate, Size 28; REF/Part#: 31-400628, Biomet Orthopedics, Inc., Warsaw, IN. |
Code Information |
Lot Number: 038730. |
Recalling Firm/ Manufacturer |
Biomet, Inc. 56 E Bell Dr Warsaw IN 46581-0587
|
For Additional Information Contact | 800-348-9500 Ext. 3913 |
Manufacturer Reason for Recall | The instrument will not lock onto the impactor handle; the device was distributed without assembly of the Bal Seal component. |
FDA Determined Cause 2 | Process control |
Action | Distributors were notified of the device defect by letter (Urgent Field Correction Notice) dated 10/18/07, and provided with assembly instructions and parts, and instructed to make corrections at consignee locations. |
Quantity in Commerce | 141 total for all recalls Z-0700-0705-2008 |
Distribution | Worldwide-USA, Germany, The Netherlands, Sweden and The United Kingdom. |
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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