The Recall Desk
SevereFDA (Devices)·Z-1157-2013·Announced 2013-05-01

Spinal Solutions Recalls APLIF Implants Due to Inadequate Testing

Spinal Solutions is recalling 220 APLIF implants because they lack adequate testing to prove safety. The defect could cause implant breakage or movement.

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 medical implant that could cause patient harm through breakage or movement, meeting the criteria for a Severe rating.

Plain-English summary

Spinal Solutions, LLC is recalling 220 units of the APLIF Implants and Instruments system. The recall covers specific part numbers for Anterior Psoas Lumbar implants, including various sizes and angles. The products were distributed nationwide, including in Nevada, Wisconsin, Maryland, and California.

The recall was initiated because the APLIF system is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. These inadequacies might result in product performance failures that could cause patient harm due to implant breakage, movement, or inadequate sterilization.

The APLIF system is indicated for intervertebral body fusion of the lumbar spine in skeletally mature patients. All lots are subject to this recall. Patients who have received these implants should contact their healthcare provider for guidance.

The recalled product

Product
APLIF Implants and Instruments, Part Numbers: 184008-10 Anterior Psoas Lumbar 18 x 40 x 08mm - 10degree 184010-10 Anterior Psoas Lumbar 18 x 40 x 10mm - 10degree 184012-10 Anterior Psoas Lumbar 18 x 40 x 12mm - 10degree 184014-10 Anterior Psoas Lumbar 18 x 40 x 14mm - 10d
Manufacturer
Spinal Solutions, LLC
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
220

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 (1)

  • All lots are subject to this recall.

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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