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Class 2 Device Recall PANTERA Proximal Humerus Fracture Plate System |
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Date Initiated by Firm |
June 05, 2013 |
Create Date |
December 04, 2019 |
Recall Status1 |
Terminated 3 on September 16, 2020 |
Recall Number |
Z-0599-2020 |
Recall Event ID |
83963 |
510(K)Number |
K081608
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Product Classification |
Plate, fixation, bone - Product Code HRS
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Product |
PANTERA Proximal Humerus Fracture Plate System |
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 |
Recalling Firm/ Manufacturer |
Toby Orthopaedics, Inc. 6355 Sw 8th St Ofc 101 West Miami FL 33144-4860
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For Additional Information Contact |
Eduardo Gonzalez-Hernandez 305-665-8699
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Manufacturer Reason for Recall |
Potential suture clip breaking during a humerus fixation surgery.
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FDA Determined Cause 2 |
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 |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = HRS and Original Applicant = TOBY ORTHOPAEDICS, LLC
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