| | Class 3 Device Recall Biomet Graft Preparation System |  |
| Date Initiated by Firm | June 11, 2007 |
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| Date Posted | July 04, 2007 |
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| Recall Status1 |
Terminated 3 on December 05, 2007 |
| Recall Number | Z-0994-2007 |
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| 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). |
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| Code Information |
Lot 192380, exp. Jan 2012. |
| FEI Number |
1825034
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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 |
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| Action | Consignees were notified by letter dated either 6/11/07 or 6/13/07 and requested to return the product. |
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| Quantity in Commerce | 5 to Europe |
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| Distribution | Worldwide, including USA, Chile, Italy, Spain and United Kingdom. |
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| 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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