Z-1466-2015Class II

Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109

Name: Z-1466-2015 Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109
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 Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine with an interspinous... 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-1466-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-12
Posted: 2015-04-20
Terminated: 2015-09-16
Recalling firm: Highridge Medical, LLC
Product: Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine with an interspinous fixation device.
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: 874
Distribution: Worldwide Distribution - US Nationwide
Product codes and lots: 538133,538134,548080,550475,552169,553131,553710,558873,567568,569141 Part Number: 6200-1109 2009300344 to 2009300543 2009300544 to 2009300643 2009300644 to 2009300743 2009300744 to 2009300843 2009300844 to 2009300993 2009411328 to 2009411377 2010082160 to 2010082257 2010152507 to 2010152571 2010373025 to 2010373174

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1466-2015
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)