Home / Recalls / Biomet Spine, LLC / Z-1089-2015

Z-1089-2015 Class II Terminated

Recalled by Biomet Spine, LLC — Broomfield, CO

FDA device recall Z-1089-2015 was initiated by Biomet Spine, LLC on December 19, 2011 and is designated Class II. 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 c… The recall status is terminated (terminated March 23, 2015). Affected quantity: 10.

Recall Details

Product Type
Devices
Report Date
February 18, 2015
Initiation Date
December 19, 2011
Termination Date
March 23, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10

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.

Distribution Pattern

Distributed to TX, OH, NE and NY.

Code Information

LOT Numbers: L561968 and L570545 Product Code: 7703-1600

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FDA data resources