Z-1089-2015Class II

Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within...

Name: Z-1089-2015 Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within...
Creator: Biomet Spine, LLC
Published: 2011-12-19
License: https://open.fda.gov/license/

Highridge Medical, LLC / initiated 2011-12-19 / Terminated / root cause: design

FDA source

Biomet Spine, LLC began a recall of Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an aluminum sterilization case along with other... on 2011-12-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1089-2015
Classification: Class II
Status: Terminated
Initiated: 2011-12-19
Posted: 2015-02-11
Terminated: 2015-03-23
Recalling firm: Highridge Medical, LLC
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.
Product code: NKB Thoracolumbosacral Pedicle Screw System
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 10
Distribution: Distributed to TX, OH, NE and NY.
Product codes and lots: LOT Numbers: L561968 and L570545 Product Code: 7703-1600

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1089-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1089-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-10

Product code NKB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)