Z-2076-2014Class II

Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer Surgical Cable Plate System...

Name: Z-2076-2014 Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer Surgical Cable Plate System...
Creator: Pioneer Surgical Technology, Inc.
Published: 2014-06-11
License: https://open.fda.gov/license/

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) / initiated 2014-06-11 / Terminated / root cause: manufacturing process

FDA source

PIONEER SURGICAL TECHNOLOGY, INC. began a recall of 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... on 2014-06-11. FDA classified it as Class II and gives the reason as "Lack of Sterility Assurance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2076-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-11
Posted: 2014-07-17
Terminated: 2014-10-22
Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Product: 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.
Product code: JDQ Cerclage, Fixation
Reason for recall: Lack of Sterility Assurance
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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.
Quantity in commerce: 5
Distribution: US Nationwide Distribution in the states of TX and FL
Product codes and lots: Model: 86-27-12-S12 UDI Number: 00846468061463 LOT: 168952 Expiration:12/23/2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2076-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2076-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-17

Product code JDQ

K133785Class IITritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. / cleared 2014-01-27

MDM coverage of this record lists here, newest first.

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)