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Terminated

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.

FDA Recall Z-1089-2015 · Posted 2015-02-11

Recalling FirmBiomet Spine, LLC
Recall StatusTerminated
Product CodeNKB
Date Initiated2011-12-19
Date Terminated2015-03-23
Product Quantity10

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.

Firm Action

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.

Root Cause

Device Design

Distribution Pattern

Distributed to TX, OH, NE and NY.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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