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.
Recall
- Recall Number
- Z-1089-2015
- Event Number
- 70376
- Firm
- Biomet Spine, LLC
- FEI Number
- 3012447612
- Product Code
- NKB
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- December 19, 2011
- Posted
- February 11, 2015
- Terminated
- March 23, 2015
- Address
- 310 Interlocken Pkwy, Ste 120, Broomfield, CO, 80021-3464
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.
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.
Consignees were informally contacted 12/16/2011 of units in the field requesting retrieval. All units were in Lanx's (Biomet's) possession at the time of the recall initiation on 12/19/2011.
Distributed to TX, OH, NE and NY.
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