CLASS II Device recall · Reported 18 Feb 2015 · FDA Enforcement Report

Telluride Percutaneous Rod Inserter Long recalled by Biomet Spine

Biomet Spine is recalling Telluride Percutaneous Rod Inserter Long, distributed in Nebraska, New York, Ohio, Texas. The recall was initiated on 19 Dec 2011 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLOT Numbers: L561968 and L570545 Product Code: 7703-1600

Quantity recalled10

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1089-2015
FDA event ID: 70376
Recalling firm: Biomet Spine, Broomfield, CO
Classification: Class II
Status: Terminated
Recall initiated: 19 Dec 2011
FDA classified: 10 Feb 2015
Reported: 18 Feb 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Hip & Knee Implants

Timeline

19 Dec 2011	Recall initiated by company
10 Feb 2015	Classified by FDA	+1149 days
18 Feb 2015	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Distributed to TX, OH, NE and NY.

Nebraska New York Ohio Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Distributed to TX, OH, NE and NY.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Biomet Spine

All 14

Reported	Class	Recall	Company	Reason	Where
6 Apr 2016Device	CLASS II	X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System recalled	Biomet Spine	Labeling Errors	Nationwide
11 Nov 2015Device	CLASS II	MaxAn and fixed screws, used recalled by Biomet Spine	Biomet Spine	Packaging Defects	FL, MO, NY
16 Sep 2015Device	CLASS II	Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft recalled	Biomet Spine	Foreign Material	Nationwide
16 Sep 2015Device	CLASS II	Biomet Parsippany, NJ recalled by Biomet Spine	Biomet Spine	Labeling Errors	Nationwide
29 Jul 2015Device	CLASS II	Polaris 4.75 TI Spinal System, Closed MAS recalled by Biomet Spine	Biomet Spine	Potency & Assay	Nationwide

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Device Malfunction	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide