Data Foundry

Medical device recalls 2015

Telluride Percutaneous Rod Inserter Long — Class II medical device recall Z-1089-2015

Terminated recall by Biomet Spine, LLC, reported 2015-02-18, distributed in NE, NY, OH, TX. The Telluride Percutaneous Rod Inserter Long does not contain a feature that locks the Rod in place during use

Recall numberZ-1089-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBiomet Spine, LLC, Broomfield, CO, United States
Recall initiated2011-12-19
Classified2015-02-10
Reported by FDA2015-02-18
Terminated2015-03-23
DistributedNE, NY, OH, TX
Quantity10
Lot numbersL561968, L570545
Model numbers7706-1904

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1089-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.