Date Initiated by Firm |
March 19, 2012 |
Date Posted |
May 29, 2012 |
Recall Status1 |
Terminated 3 on June 20, 2012 |
Recall Number |
Z-1676-2012 |
Recall Event ID |
61756 |
510(K)Number |
K102402
|
Product Classification |
Intervertebral fusion device with bone graft, lumbar - Product Code MAX
|
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.
|
Code Information |
Part Numbers: 25975 & 25976. Product Code(s): MAX. Market Clearance: 510(k) K102402. |
Recalling Firm/ Manufacturer |
Alphatec Spine, Inc. 5818 El Camino Real Carlsbad CA 92008-8816
|
For Additional Information Contact |
760-431-9286
|
Manufacturer 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.
|
FDA Determined Cause 2 |
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 in Commerce |
18 devices |
Distribution |
Worldwide Distribution - USA (nationwide) and Germany |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = MAX and Original Applicant = ALPHATEC SPINE, INC.
|