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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-0994-2007 |
| Recall Event ID |
38116 |
| Product Classification |
bone graft preparation syringe - Product Code FMF
|
| Product |
Vortech Graft Preparation System, sterile, single use, disposable, Distributed by Biomet Biologics, Inc., Warsaw, Indiana; REF 800-0300V. (Not sold in the United States). |
| Code Information |
Lot 192380, exp. Jan 2012. |
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.
|
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 |
5 to Europe |
| 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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