Biomet Spine, LLC: Medical Device Recall in 2015 - (Recall #: Z-1089-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 19, 2011

Date Posted: February 18, 2015

Recall Number: Z-1089-2015

Event ID: 70376

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.

Status: Terminated

Product Quantity: 10

Code Information:

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

Distribution Pattern:

Distributed to TX, OH, NE and NY.

Voluntary or Mandated:

Voluntary: Firm initiated