Z-0599-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 11, 2019
- Initiation Date
- June 5, 2013
- Termination Date
- September 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1700 devices
Product Description
PANTERA Proximal Humerus Fracture Plate System
Reason for Recall
Potential suture clip breaking during a humerus fixation surgery.
Distribution Pattern
Arkansas, Florida, Puerto Rico, Spain, Panama, Australia, UK
Code Information
1. All implanted plates in the US from 11/26/10 to 06/05/2013 with catalog numbers TO-PHP-L73, TO-PHP-R73, TO-PHP-L83, TO-PHP-R83, TO-PHP-L120, TO-PHP-R120, TO-PHP-L160, TO-PHP-R160, TO-PHP-L180, TO-PHP-R180, TO-PHP-L220, TO-PHP-R120, TO-PHP-LS, TO-PHP-RS, TO-PHP-LE, TO-PHP-RE; 2. All implanted plates in Spain and Italy from 11/26/10 to 03/26/2014, with catalog numbers TO-PHP-L73, TO-PHP-R73, TO-PHP-L83, TO-PHP-R83, TO-PHP-L120, TO-PHP-R120, TO-PHP-L160, TO-PHP-R160, TO-PHP-L180, TO-PHP-R180, TO-PHP-L220, TO-PHP-R120, TO-PHP-LS, TO-PHP-RS, TO-PHP-LE, TO-PHP-RE; 3. All implanted plates in Panama from 11/26/10 to 05/27/2014, with catalog numbers TO-PHP-L73, TO-PHP-R73, TO-PHP-L83, TO-PHP-R83, TO-PHP-L120, TO-PHP-R120, TO-PHP-L160, TO-PHP-R160, TO-PHP-L180, TO-PHP-R180, TO-PHP-L220, TO-PHP-R120, TO-PHP-LS, TO-PHP-RS, TO-PHP-LE, TO-PHP-RE 4. All implanted plates in Puerto Rico, Chile and Argentina from 11/26/10 to 04/11/2014, with catalog numbers TO-PHP-L73, TO-PHP-R73, TO-PHP-L83, TO-PHP-R83, TO-PHP-L120, TO-PHP-R120, TO-PHP-L160, TO-PHP-R160, TO-PHP-L180, TO-PHP-R180, TO-PHP-L220, TO-PHP-R120, TO-PHP-LS, TO-PHP-RS, TO-PHP-LE, TO-PHP-RE; 5. All implanted plates in Australia from 11/26/10 to 09/09/2015, with catalog numbers TO-PHP-L73, TO-PHP-R73, TO-PHP-L83, TO-PHP-R83, TO-PHP-L120, TO-PHP-R120, TO-PHP-L160, TO-PHP-R160, TO-PHP-L180, TO-PHP-R180, TO-PHP-L220, TO-PHP-R120, TO-PHP-LS, TO-PHP-RS, TO-PHP-LE, TO-PHP-RE