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.
This recall has been terminated (originally issued February 11, 2015).
- Company
- Biomet Spine Llc.
- Recall Initiated
- December 19, 2011
- Posted
- February 11, 2015
- Terminated
- March 23, 2015
- Recall Number
- Z-1089-2015
- Quantity
- 10
- Firm Location
- Broomfield, CO
- Official Source
- View on FDA website ↗
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.
Distribution
Distributed to TX, OH, NE and NY.
Lot / Code Info
LOT Numbers: L561968 and L570545 Product Code: 7703-1600
Root Cause
Device Design
Action Taken
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.
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