FDA recall Z-0599-2020
Toby Orthopaedics, Inc. · Class II · device
Product
PANTERA Proximal Humerus Fracture Plate System
Reason for recall
Potential suture clip breaking during a humerus fixation surgery.
Distribution
Arkansas, Florida, Puerto Rico, Spain, Panama, Australia, UK
Key facts
- Status
- Terminated
- Initiation date
- 2013-06-05
- Report date
- 2019-12-11
- Termination date
- 2020-09-16
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- West Miami, FL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0599-2020