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Class 3 Device Recall Biomet Graft Preparation System |
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Date Initiated by Firm |
June 11, 2007 |
Date Posted |
July 04, 2007 |
Recall Status1 |
Terminated 3 on December 05, 2007 |
Recall Number |
Z-0993-2007 |
Recall Event ID |
38116 |
510(K)Number |
K021071
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Product Classification |
bone graft preparation syringe - Product Code FMF
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Product |
Graft Preparation System, sterile, single use, disposable, Distributed by Biomet Biologics, Inc., Warsaw, Indiana; REF 800-0300. |
Code Information |
Lots 192180, exp. Jan 2012; 223260, exp. Jan 2012 and 652330, exp May 2011. |
Recalling Firm/ Manufacturer |
Biomet, Inc. 56 E Bell Dr Warsaw IN 46581-0587
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For Additional Information Contact |
574-267-6639
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Manufacturer Reason for Recall |
The syringe assembly has an obstruction in the tube that prevents the plunger from being depressed.
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FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by letter dated either 6/11/07 or 6/13/07 and requested to return the product. |
Quantity in Commerce |
46 to U.S. and international |
Distribution |
Worldwide, including USA, Chile, Italy, Spain and 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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510(K) Database |
510(K)s with Product Code = FMF and Original Applicant = BIOMET, INC.
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