Tritium Sternal Cable Plate System recallZ-2076-2014 · Pioneer Surgical Technology, Inc. · initiated Jun 11, 2014
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Pioneer Surgical Technology, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Lack of Sterility Assurance
FDA root cause category: Employee error
What the company is doing
On 6/11/14 and 6/12/14 the firm contacted their two consignees and surgeon via phone and explained that the product did not go through the sterilization process. The returns authorization number and shipping labels were discussed for the unused unit. On 6/18/14 and 6/20/14 an URGENT: MEDICAL DEVICE VOLUNTARY RECALL NOTIFICATION was sent to the customers as well as the one surgeon. The letter explained the sterility concerns and that the productis being recalled. Contact Dan Nelson, Manager of Quality, at 906-226-4489 if you have any questions or concerns.
Recall details
- Recall number
- Z-2076-2014
- Status
- Terminated
- Initiated by the company
- Jun 11, 2014
- Posted by the FDA
- Jul 17, 2014
- Recalling firm
- Pioneer Surgical Technology, Inc.
- Quantity
- 5
- Product code
- JDQ
- FDA submissions
- K133785
- Distribution
- US Nationwide Distribution in the states of TX and FL
Product description
Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer Surgical Cable Plate System is used in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures. The screws are packaged as a 12 pack using a double tray packaging configuration.
Code information (models, lots, serial numbers)
Model: 86-27-12-S12 UDI Number: 00846468061463 LOT: 168952 Expiration:12/23/2018
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Tritium® Sternal Cable Plate System 86-27-12-S12Pioneer Surgical Technology, Inc. · CERCLAGE, FIXATION1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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