Reported Jul 23, 2014 · Terminated
Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer Surgical Cable Plate System is used…
Pioneer Surgical Technology, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PIONEER SURGICAL TECHNOLOGY, INC. · 375 River Park Cir · Marquette, MI · 49855-1781
Is this the product you have?
- 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.
- Lot codes and dates
- Model86-27-12-S12
- UDI Number00846468061463
- LOT168952
- Expiration12/23/2018
- Amount recalled
- 5
Where it was sold
Why it was recalled
Lack of Sterility Assurance
This product could cause temporary or reversible health problems — stop using it.
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