Recall Z-1069-2015 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Biomet Spine, LLC
Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided within an aluminum sterilization tray along with other instruments for use in a Timberline procedure Timberline Anchored Lateral Retractable Drills are used with the Timberline Lateral System to establish access into the vertebrae for the screws utilized to anchor the plate to the
| Date | Feb 9, 2015 (initiated Feb 22, 2012) |
| Status | Terminated |
| Reason | Biomet Spine, LLC is recalling the Timberline Cranial Caudal and Posterior Blades, 40-180mm due to oversize of the set screw hex feature. |
| Root cause | Nonconforming Material/Component |
| Action | Biomet initiated the recall on February 22, 2012, No letters were or will be sent to customers. 100% retrieval was achieved by working directly with the customers. For questions regarding this recall call 303-501-8548. |
| Quantity | 213 |
| Distribution | Distributed to TX, IN, MO, and NY. No foreign/govt/military/VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.