FDA Medical Device Recalls (openFDA)
Biomet Spine LLC.: 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.
- Recall number
- Z-0220-2015
- Recalling firm
- Biomet Spine 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.
- Status
- Terminated
- Initiated
- 2011-03-09
- Posted
- 2014-12-16
- Terminated
- 2015-01-07
- Reason
- 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
- Device Design
- Action
- Biomet notified customers by phone on March 9, 2011 to return the affected product.
- Quantity
- 120
- Distribution
- US Nationwide Distribution in the states of California, Indiana, Louisiana, and Texas,
- Lot, serial or model codes
- Lot numbers L532655, L532690, Product code 8503XXXX
- 510(k) numbers
- ["K102738"]
- PMA numbers
- not on file
- Product code
- MAX
- Firm FEI
- 3012447612
- Firm city
- Broomfield
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28