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.
This recall has been terminated (originally issued May 29, 2012).
- Company
- Alphatec Spine, Inc.
- Recall Initiated
- March 19, 2012
- Posted
- May 29, 2012
- Terminated
- June 20, 2012
- Recall Number
- Z-1676-2012
- Quantity
- 18 devices
- Firm Location
- Carlsbad, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide Distribution - USA (nationwide) and Germany
Lot / Code Info
Part Numbers: 25975 & 25976. Product Code(s): MAX. Market Clearance: 510(k) K102402.
Root Cause
Device Design
Action Taken
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.