Platen, Catalog # 301-124, is a mechanism used to lock or hold the fill tube in place as it is filled with graft material. Platen is identified with Spineology, catalog number and lot number printed directly onto the metal.
FDA Recall Z-0679-05 · Posted 2005-04-06
Advertisement
Recalling FirmThe Spineology Group
Recall StatusTerminated
Product CodeLXH
Date Initiated2005-01-28
Date Terminated2005-11-17
Product Quantity40
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.
Firm 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.
Root Cause
Other
Distribution Pattern
11 consignees located in: Arkansas, Arizona, California, Georgia, Illinois, Michigan, Minnesota, North Carolina, New York, Oklahoma and United Kingdom
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement