Z-0220-2015Class II

LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case

Name: Z-0220-2015 LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case
Creator: Biomet Spine LLC.
Published: 2011-03-09
License: https://open.fda.gov/license/

Highridge Medical, LLC / initiated 2011-03-09 / Terminated / root cause: design

FDA source

Biomet Spine LLC. began a recall of LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion procedures... on 2011-03-09. FDA classified it as Class II and gives the reason as "Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly". 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-0220-2015
Classification: Class II
Status: Terminated
Initiated: 2011-03-09
Posted: 2014-12-16
Terminated: 2015-01-07
Recalling firm: Highridge Medical, LLC
Product: LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2S1.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly.
Root cause tag: design
FDA root cause: Device Design
Action: Biomet notified customers by phone on March 9, 2011 to return the affected product.
Quantity in commerce: 120
Distribution: US Nationwide Distribution in the states of California, Indiana, Louisiana, and Texas,
Product codes and lots: Lot numbers L532655, L532690, Product code 8503XXXX

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0220-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0220-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-14

Product code MAX

K102738Class IILanx Fusion SystemLanx, LLC / cleared 2011-02-10

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)