Z-0223-2020 Class II Terminated
FDA device recall Z-0223-2020 was initiated by Synthes (USA) Products LLC on September 16, 2019 and is designated Class II. Reason for recall: The subject product measures 4.0mm in diameter instead of 3.5mm. The recall status is terminated (terminated April 24, 2020). Affected quantity: 6.
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2019
- Initiation Date
- September 16, 2019
- Termination Date
- April 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6
Product Description
Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
Reason for Recall
The subject product measures 4.0mm in diameter instead of 3.5mm.
Distribution Pattern
Distributed to NJ.
Code Information
10L2702