Alphatec Spine, Inc.: SOLUS Anterior Lumbar Interbody Fusion Spinal Spacer System, Solus Proximal/Distal Deployment Wrenches, 510(k) K102402. The Alphatec Solus Anterior Lumbar Interbody Fusion (AUF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DOD) at one or two contiguous levels from L2-S1 with up to Grade 1 spondyiolisthesis or retrolisthesis at the involved level(s). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Alphatec Solus implant is intended to be used with autograft. The device is intended for use with supplemental fixation that is in addition to the integrated blades. The Alphatec Solus implant is intended for use with supplemental spinal fixation. Specifically, the Alphatec Solus implant is to be used with the Alphatec's Zodiac Spinal Fixation System, Aspida" Anterior Lumbar Plating System, or the ILLlCO MIS Posterior Fixation System. Intervertebral body fusion device.

Recall number

Z-1676-2012

Recalling firm

Alphatec Spine, Inc.

Product

SOLUS Anterior Lumbar Interbody Fusion Spinal Spacer System, Solus Proximal/Distal Deployment Wrenches, 510(k) K102402. The Alphatec Solus Anterior Lumbar Interbody Fusion (AUF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DOD) at one or two contiguous levels from L2-S1 with up to Grade 1 spondyiolisthesis or retrolisthesis at the involved level(s). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Alphatec Solus implant is intended to be used with autograft. The device is intended for use with supplemental fixation that is in addition to the integrated blades. The Alphatec Solus implant is intended for use with supplemental spinal fixation. Specifically, the Alphatec Solus implant is to be used with the Alphatec's Zodiac Spinal Fixation System, Aspida" Anterior Lumbar Plating System, or the ILLlCO MIS Posterior Fixation System. Intervertebral body fusion device.

Status

Terminated

Initiated

2012-03-19

Posted

2012-05-29

Terminated

2012-06-20

Reason

Alphatec Spine has received several complaints (n+4) on the Alphatec Solus Distal Deployment Wrench for twisting or bending, which has been discovered either during or after instrumentation use. A fifth complaint received in which it was reported that the spline tip of the Alphatec Solus Proximal Deployment Wrench had sheared from the instrument upon use.

Root cause

Device Design

Action

Alphatec Spine sent an Urgent Medical Device Recall Notification dated March 30, 2012, to all affected customers. The notification letter informed customers of the removal/recall and included instructions on what to do with the recalled products. Initial letter was delivered via FedEx, and followed by telephone call with a total of 4 attempts. Customers were instructed to return all of the affected product. Upon receipt of of the Medical Device Recall Notification, customers were instructed to contact Alphatec Spine's Customer Service Department immediately for instructions on how to return the instruments and fill out the lower portion of this letter to confirm that they have read the notification and have taken all necessary removal actions: Customers should return a signed copy of the form to: Alphatec Spine, Inc. 5818 El Camino Real, Carlsbad, CA 92008 ATTN: Rand Jadan Forms may also be returned via email to rjadan@alphatecspine.com or fax to 760-431-0289. For questions regarding this recall call 760-431-9286.

Quantity

18 devices

Distribution

Worldwide Distribution - USA (nationwide) and Germany

Lot, serial or model codes

Part Numbers: 25975 & 25976. Product Code(s): MAX. Market Clearance: 510(k) K102402.

510(k) numbers

["K102402"]

PMA numbers

not on file

Product code

MAX

Firm FEI

2027467

Firm city

Carlsbad

Firm state

CA

Firm country

not on file

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

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