LANX — Class II medical device recall Z-0220-2015
Terminated recall by Biomet Spine LLC., reported 2014-11-26, distributed nationwide. Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component po
| Recall number | Z-0220-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet Spine LLC., Broomfield, CO, United States |
| Recall initiated | 2011-03-09 |
| Classified | 2014-11-14 |
| Reported by FDA | 2014-11-26 |
| Terminated | 2015-01-07 |
| Distributed | Nationwide (US) |
| Quantity | 120 |
| Lot numbers | L532655, L532690 |
| Model numbers | PCR8XXX-XXX |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0220-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.