Recall Z-0849-2018— DePuy Orthopaedics, Inc.
Class II · Terminated
Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2017-07-26, terminated 2019-04-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.. Reason: Potential for Intra-operative breakage of driver tips.
- Recalling firm
- DePuy Orthopaedics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-26
- Terminated
- 2019-04-03
- Firm location
- Raynham, MA, United States
Product description
Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
Reason for recall
Potential for Intra-operative breakage of driver tips
Data sourced from openFDA. This site is unofficial and independent of the FDA.