Z-0678-05

Fill Tube,straight, Catalog # 300-1001, is used for the delivery of granular autograft or allograft into...

Name: Z-0678-05 Fill Tube,straight, Catalog # 300-1001, is used for the delivery of granular autograft or allograft into...
Creator: The Spineology Group
Published: 2005-01-28
License: https://open.fda.gov/license/

Spineology, Inc. / initiated 2005-01-28 / Terminated

FDA source

The Spineology Group began a recall of Fill Tube,straight, Catalog # 300-1001, is used for the delivery of granular autograft or allograft into Spineology''s OptiMesh implant. Fill tube is... on 2005-01-28. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0678-05
Status: Terminated
Initiated: 2005-01-28
Posted: 2005-04-06
Terminated: 2005-11-17
Recalling firm: Spineology, Inc.
Product: Fill Tube,straight, Catalog # 300-1001, 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.
Product code: LXH Orthopedic Manual Surgical Instrument
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 root cause: Other
Action: A 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 commerce: 870
Distribution: 11 consignees located in: Arkansas, Arizona, California, Georgia, Illinois, Michigan, Minnesota, North Carolina, New York, Oklahoma and United Kingdom
Product codes and lots: UN02001, 71-1057, UN04001, UN04004, and M04041

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)