Recall Z-1069-2015— Biomet Spine, LLC
Class II · Terminated
Class II FDA medical device recall by Biomet Spine, LLC, initiated 2012-02-22, terminated 2015-03-23. FDA's recall record names no specific 510(k) clearance for this event. Product: 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 vertebrae.. Reason: Biomet Spine, LLC is recalling the Timberline Cranial Caudal and Posterior Blades, 40-180mm due to oversize of the set screw hex feature..
- Recalling firm
- Biomet Spine, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-02-22
- Terminated
- 2015-03-23
- Firm location
- Broomfield, CO, United States
Product description
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 vertebrae.
Reason for recall
Biomet Spine, LLC is recalling the Timberline Cranial Caudal and Posterior Blades, 40-180mm due to oversize of the set screw hex feature.
Data sourced from openFDA. This site is unofficial and independent of the FDA.