Z-0849-2018 Class II Terminated
FDA device recall Z-0849-2018 was initiated by DePuy Orthopaedics, Inc. on July 26, 2017 and is designated Class II. Reason for recall: Potential for Intra-operative breakage of driver tips The recall status is terminated (terminated April 3, 2019). Affected quantity: 130 units total.
Recall Details
- Product Type
- Devices
- Report Date
- March 14, 2018
- Initiation Date
- July 26, 2017
- Termination Date
- April 3, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 130 units total
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
Distribution Pattern
Nationwide Distribution
Code Information
Product code: 287804102 Lot number: 122315-B R, 122315-A R, 041117A