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U.S. Department of Health and Human Services

Class 2 Device Recall Stella Interdental Osteotome

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 Class 2 Device Recall Stella Interdental Osteotomesee related information
Date Initiated by FirmApril 16, 2008
Date PostedSeptember 11, 2008
Recall Status1 Terminated 3 on September 11, 2009
Recall NumberZ-1871-2008
Recall Event ID 48458
Product Classification surgical chisel, osteotome - Product Code EMM
ProductStella 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
Manufacturer Reason
for Recall		The working tips of the Stella Osteotomes are thicker than specification.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe 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 Commerce36
DistributionDistributed domestically to Missouri, New Mexico and Texas, and countries of Canada and Germany.
Total Product Life CycleTPLC Device Report
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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