Fill Tube,diverted, Catalog # 300-1002, is used for the delivery of granular autograft or allograft into Spineology''s O

FDA device recall Z-0677-05 · posted 2005-04-06 · Terminated

Recall details

Recalling firm

The Spineology Group

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

LXH

Quantity affected

3392

Distribution

11 consignees located in: Arkansas, Arizona, California, Georgia, Illinois, Michigan, Minnesota, North Carolina, New York, Oklahoma and United Kingdom

Date initiated

2005-01-28

Date posted

2005-04-06

Date terminated

2005-11-17

Location

Stillwater, MN