Date Initiated by Firm |
April 16, 2008 |
Date Posted |
September 11, 2008 |
Recall Status1 |
Terminated 3 on September 11, 2009 |
Recall Number |
Z-1871-2008 |
Recall Event ID |
48458 |
Product Classification |
surgical chisel, osteotome - Product Code EMM
|
Product |
Stella Interdental Osteotome, 4mm, 6mm and 8mm. Model numbers 01-0575, 01-0576 and 01-0578. Product is intended to be used during the interdental osteotomy (bone cutting). |
Code Information |
Lot numbers: 381250, 381251, 439970, 381240, 356510,513250 and 354320. |
Recalling Firm/ Manufacturer |
Biomet Microfixation, Inc. 1520 Tradeport Dr Jacksonville FL 32218-2480
|
For Additional Information Contact |
904-741-4400
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Manufacturer Reason for Recall |
The working tips of the Stella Osteotomes are thicker than specification.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
The firm notified its consignees on 4/16/08 by certified mail with return receipt. Sub-accounts were contacted by email. All returned product will be stored in quarantine until a final determination of disposition is made. |
Quantity in Commerce |
36 |
Distribution |
Distributed domestically to Missouri, New Mexico and Texas, and countries of Canada and Germany. |
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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