Recall Z-1089-2015— Biomet Spine, LLC
Class II · Terminated
Class II FDA medical device recall by Biomet Spine, LLC, initiated 2011-12-19, terminated 2015-03-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an aluminum sterilization case along with other orthopedic manual surgical instruments. The case consists of three trays of instruments, and the middle tray contains a quantity of two Inserters. The Inserter is for use as part of a Telluride System pedicle screw procedure.. Reason: The Telluride Percutaneous Rod Inserter Long does not contain a feature that locks the Rod in place during use. There is a potential for the Rod to disengage from the Inserter during insertion, and could lead to harm to the patient..
- Recalling firm
- Biomet Spine, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-12-19
- Terminated
- 2015-03-23
- Firm location
- Broomfield, CO, United States
Product description
Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an aluminum sterilization case along with other orthopedic manual surgical instruments. The case consists of three trays of instruments, and the middle tray contains a quantity of two Inserters. The Inserter is for use as part of a Telluride System pedicle screw procedure.
Reason for recall
The Telluride Percutaneous Rod Inserter Long does not contain a feature that locks the Rod in place during use. There is a potential for the Rod to disengage from the Inserter during insertion, and could lead to harm to the patient.
Data sourced from openFDA. This site is unofficial and independent of the FDA.