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U.S. Department of Health and Human Services

Class 3 Device Recall Spineology Fill Tube, diverted

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 Class 3 Device Recall Spineology Fill Tube, divertedsee related information
Date Initiated by FirmJanuary 28, 2005
Date PostedApril 06, 2005
Recall Status1 Terminated 3 on November 17, 2005
Recall NumberZ-0677-05
Recall Event ID 31198
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
ProductFill Tube,diverted, Catalog # 300-1002, is used for the delivery of granular autograft or allograft into Spineology''s OptiMesh implant. Fill tube is identified with Spineology, catalog number and lot number printed directly onto the metal.
Code Information Lot # UN02002, 71-1057, UN04003 and UN04004
Recalling Firm/
Manufacturer		 The Spineology Group
1815 Northwestern Ave S
Stillwater MN 55082-6500
For Additional Information ContactPat Commerford
651-856-8517
Manufacturer Reason
for Recall		Three malfunctions, due to jamming of bone material in the fill tube occurred, which allowed the fill tube to advance more deeply than intended into the surgical site. Fill tubes are used in delivery of bone graft materials.
FDA Determined
Cause 2		Other
ActionA Product Update, January 2005 (Vol. 2) was e-mailed to all representatives and also sent by mail on January 28, 2005. Telephone calls to each distributor/representative were made by Spineology Sales & Marketing staff between January 28 and January 31. The Product Update informs customers that they will be receiving new tubes and new platens soon and that any tubes and platens currently in their possession should be returned to Spineology.
Quantity in Commerce3392
Distribution11 consignees located in: Arkansas, Arizona, California, Georgia, Illinois, Michigan, Minnesota, North Carolina, New York, Oklahoma and United Kingdom
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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