Recall Z-0454-2016— DePuy Spine, Inc.
Class II · Terminated
Class II FDA medical device recall by DePuy Spine, Inc., initiated 2015-11-20, terminated 2017-07-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.. Reason: Manufacturing error within the Torque Handle may prohibit some handles from being able to fully assemble with the tightener shaft. The design of the inspection gage does not account for the additional shift length.
- Recalling firm
- DePuy Spine, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-20
- Terminated
- 2017-07-03
- Firm location
- Raynham, MA, United States
Product description
Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.
Reason for recall
Manufacturing error within the Torque Handle may prohibit some handles from being able to fully assemble with the tightener shaft. The design of the inspection gage does not account for the additional shift length
Data sourced from openFDA. This site is unofficial and independent of the FDA.