Z-2759-2015Class II

Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and...

Name: Z-2759-2015 Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and...
Creator: Biomet Spine, LLC
Published: 2015-07-22
License: https://open.fda.gov/license/

Highridge Medical, LLC / initiated 2015-07-22 / Terminated / root cause: design

FDA source

Biomet Spine, LLC began a recall of Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap... on 2015-07-22. FDA classified it as Class II and gives the reason as "Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft instrumentsafter identifying that these instruments were distributed prior to completion of all design control activities". 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-2759-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-22
Posted: 2015-09-10
Terminated: 2015-12-10
Recalling firm: Highridge Medical, LLC
Product: Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch. The Lineum system is designed to facilitate reconstruction of the cervical and upper thoracic spine using bone screws, locking plugs, and various types of rods, hooks, and lateral connectors. One of the instruments used with this system is the Lineum Occipital Screw Starter with the inner shaft subassembly. The system comes with a fixed shaft Lineum Occipital Screw Driver, and a 90 driver in order to retain and drive the screw into the occipital bone.
Product code: KWP Appliance, Fixation, Spinal Interlaminal
Reason for recall: Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft instrumentsafter identifying that these instruments were distributed prior to completion of all design control activities.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter dated 7/23/2015 to their Consignees/Customers via certified letter. The letter described the product, problem and actions to be taken. The customers were instructed to immediately locate and discontinue use of device; remove from circulation; carefully follow instructions on enclosed "Response Form" and complete and return via fax to 303.501.8444; if you have further distributed these devices to medical facilities, you MUST notify them of this action; and return device and form to Zimmer Biomet Spine, 310 Interlocken Pkwy, Ste 120, Broomfield, CO 80021. Questions related to this notice should be directed to the Quality Engineer at 303-501-8457 Monday through Friday, 8 a.m. to 5 p.m. MST.
Quantity in commerce: 49
Distribution: Worldwide Distribution: US (nationwide) in states of: NY, MO, WI, IN, CA, NC, and OH, and to countries of: Japan and Netherlands.
Product codes and lots: P/N 14-525050 Lot Number 001219 P/N 14-525057 Lot Number 001220

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2759-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2759-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-16	2015-09-10

Product code KWP

K122378Class IINextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) / cleared 2012-09-20

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)