Recall Z-0677-05 ยท LXH Orthopedic Manual Surgical Instrument
The Spineology Group
Fill 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.
| Date | Apr 6, 2005 (initiated Jan 28, 2005) |
| Status | Terminated |
| Reason | 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. |
| 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 | 3392 |
| Distribution | 11 consignees located in: Arkansas, Arizona, California, Georgia, Illinois, Michigan, Minnesota, North Carolina, New York, Oklahoma and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.