The Spineology Group 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
The Spineology Group
Lot Codes / Batch Numbers
UN02001, 71-1057, UN04001, UN04004, and M04041
Products Sold
UN02001, 71-1057, UN04001, UN04004, and M04041
The Spineology Group is recalling Fill Tube,straight, Catalog # 300-1001, is used for the delivery of granular autograft or allograft due to 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 t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, AR, CA, GA, IL, IN, MI, MN, NY, NC, OK
Page updated: Jan 10, 2026