SOLUS Anterior Lumbar Interbody Fusion Spinal Spacer System, Solus Proximal/Distal Deployment Wrenches, 510(k) K102402.

FDA device recall Z-1676-2012 · posted 2012-05-29 · Terminated

Recall details

Recalling firm

Alphatec Spine, Inc.

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.

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.

Root cause

Device Design

Status

Terminated

Product code

MAX

Quantity affected

18 devices

Distribution

Worldwide Distribution - USA (nationwide) and Germany

Date initiated

2012-03-19

Date posted

2012-05-29

Date terminated

2012-06-20

Location

Carlsbad, CA

Related 510(k) clearances