Z-0599-2020Class II

PANTERA Proximal Humerus Fracture Plate System

Name: Z-0599-2020 PANTERA Proximal Humerus Fracture Plate System
Creator: Toby Orthopaedics, Inc.
Published: 2013-06-05
License: https://open.fda.gov/license/

Toby Orthopaedics / initiated 2013-06-05 / Terminated / root cause: labeling and UDI

FDA source

Toby Orthopaedics, Inc. began a recall of PANTERA Proximal Humerus Fracture Plate System on 2013-06-05. FDA classified it as Class II and gives the reason as "Potential suture clip breaking during a humerus fixation surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0599-2020
Classification: Class II
Status: Terminated
Initiated: 2013-06-05
Posted: 2019-12-04
Terminated: 2020-09-16
Recalling firm: Toby Orthopaedics
Product: PANTERA Proximal Humerus Fracture Plate System
Product code: HRS Plate, Fixation, Bone
Reason for recall: Potential suture clip breaking during a humerus fixation surgery.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Beginning on 06/05/2013 the firm notified their direct consignees of the change in the instructions for use (IFU). On 10/11/2019, the firm followed up with the direct accounts (distributors) to reach out to the users to inform them of the change.
Quantity in commerce: 1700 devices
Distribution: Arkansas, Florida, Puerto Rico, Spain, Panama, Australia, UK
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0599-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0599-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-11	2019-12-04

Product code HRS

K081608Class IIProximal Humerus Scaffold Fixation System (Phsfs)Toby Orthopaedics, LLC / cleared 2008-12-19

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)