APLIF Implants and Instruments, Part Numbers: 184008-10 Anterior Psoas Lumbar 18 x 40 x 08mm - 10degree 184010-10 Anteri

FDA device recall Z-1157-2013 · posted 2013-04-22 · Terminated

Recall details

Recalling firm

Spinal Solutions, LLC

Reason for recall

Spinal Solutions is recalling the APLIF system because it 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.

Action taken

Spinal Solutions LLC sent an Urgent Medical Device Recall letter dated April 12, 2013, to all affected customers. The letter informed the customers of the problem identified and the actions to be taken. Customers were instructed to discontinue use of the affected product and return to the firm. Customers were also instructed to complete the bottom of the form and to return it by fax to (858) 764-9739. For questions regarding this recall call 951-304-9001.

Root cause

No Marketing Application

Status

Terminated

Product code

MAX

Quantity affected

220 units

Distribution

Nationwide Distribution including NV, WI, MD,and CA.

Date initiated

2013-03-08

Date posted

2013-04-22

Date terminated

2014-03-26

Location

Murrieta, CA