Z-1465-2015Class II

Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to facilitate...

Name: Z-1465-2015 Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to facilitate...
Creator: Biomet Spine, LLC
Published: 2015-03-12
License: https://open.fda.gov/license/

Highridge Medical, LLC / initiated 2015-03-12 / Terminated / root cause: design

FDA source

Biomet Spine, LLC began a recall of Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to facilitate reconstruction of the cervical and upper thoracic spine... on 2015-03-12. FDA classified it as Class II and gives the reason as "Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market for component updates or reconfiguration". 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-1465-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-12
Posted: 2015-04-20
Terminated: 2015-09-16
Recalling firm: Highridge Medical, LLC
Product: Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to facilitate reconstruction of the cervical and upper thoracic spine using bones screws, locking plugs, and various types of rods, hooks, and lateral connectors.
Product code: HXC Wrench
Reason for recall: Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market for component updates or reconfiguration.
Root cause tag: design
FDA root cause: Component design/selection
Action: Biomet sent an Urgent Medical Device Recall Notice dated March 12, 2015 via phone and customer letters. The letter identified the affected product, problem and actions to be taken. Customers were asked to follow the instructions on the enclosed "Response Form". For questions call 858-232-2672.
Quantity in commerce: 148
Distribution: Worldwide Distribution - US Nationwide
Product codes and lots: 538133 ,538134 ,548080 ,550475 ,552169 ,553131, 553710 ,558873 ,567568 ,569141

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1465-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1465-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-20
Z-1466-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-20

Product code HXC

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)