Biomet Spine Recalls Durango Anchored ALIF Plate Due to Set Screw Risk
Biomet Spine is voluntarily recalling 120 Durango Anchored ALIF Plate units because the set screw component may become dislodged from the plate assembly.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a spinal implant where a component may become dislodged, posing a significant risk of injury.
Plain-English summary
Biomet Spine, LLC. has announced a voluntary recall of the Durango Anchored ALIF Plate. The recall is being conducted because the set screw component of the device may become dislodged from the plate assembly. The affected product is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease.
The recall involves 120 units of the device, which are packaged within aluminum sterilization cases. The specific lot numbers affected are L532655 and L532690, with product code 8503XXXX. The agency classifies this recall as Class II.
The affected units were distributed nationwide in the United States, specifically in the states of California, Indiana, Louisiana, and Texas. Healthcare providers and patients who have received this device should contact Biomet Spine, LLC. for further instructions regarding the recall and potential replacement or repair.
The recalled product
- 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 tw
- Manufacturer
- Biomet Spine LLC.
- Category
- Medical Device — Spinal Implant
- Affected units
- 120
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot numbers L532655
- L532690
- Product code 8503XXXX
Distribution
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