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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69615

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
March 09, 2011
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Biomet Spine LLC.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0220-2015
Recall number
Z-0220-2015
Initiated
March 09, 2011
Classification
Class II
Status
Terminated
Recalling firm
Biomet Spine LLC.
Quantity
120

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot numbers L532655, L532690, Product code 8503XXXX

Distribution pattern

US Nationwide Distribution in the states of California, Indiana, Louisiana, and Texas,