Data Foundry

Medical device recalls 2019

PANTERA Proximal Humerus Fracture Plate System — Class II medical device recall Z-0599-2020

Terminated recall by Toby Orthopaedics, Inc., reported 2019-12-11, distributed in AR, FL, PR. Potential suture clip breaking during a humerus fixation surgery.

Recall numberZ-0599-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmToby Orthopaedics, Inc., West Miami, FL, United States
Recall initiated2013-06-05
Classified2019-12-04
Reported by FDA2019-12-11
Terminated2020-09-16
DistributedAR, FL, PR
Countries outside the USAU, ES, GB, PA
Quantity1,700 devices
Model numbersTO-PHP-L120, TO-PHP-L160, TO-PHP-L180, TO-PHP-L220, TO-PHP-L73, TO-PHP-L83, TO-PHP-R120, TO-PHP-R160, TO-PHP-R180, TO-PHP-R73, TO-PHP-R83

Product

PANTERA Proximal Humerus Fracture Plate System

Reason for recall

Potential suture clip breaking during a humerus fixation surgery.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0599-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.