Reported Dec 11, 2019 · Terminated
PANTERA Proximal Humerus Fracture Plate System
Toby Orthopaedics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Toby Orthopaedics, Inc. · 6355 Sw 8th St Ofc 101 · West Miami, FL · 33144-4860
Is this the product you have?
- PANTERA Proximal Humerus Fracture Plate System
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 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 - Amount recalled
- 1700 devices
Where it was sold
Why it was recalled
Potential suture clip breaking during a humerus fixation surgery.
This product could cause temporary or reversible health problems — stop using it.
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