PERPOS PLS System, Single Use; CATALOG #'s 9045-01 & 9045-02. Interventional Spine, Inc. A sterile kit used to stabilize

FDA device recall Z-0045-2012 · posted 2011-10-13 · Terminated

Recall details

Recalling firm

Interventional Spine Inc

Reason for recall

This recall has been initiated due to drivers that may contain a burr in the distal tip preventing full seating of the driver onto the head of the facet screw, resulting in difficulty screwing the facet screw into the bone. Use of this product may result in a delay of the surgical procedure

Action taken

Interventional Spine, Inc. sent an "Urgent Recall" letter dated March 15, 2011 to all affected customers. The letter included; affected product, reason for recall and recommendations. Customers were asked to immediately examine inventory, quarantine affected product and to notify International Spine, Inc if any product remain. For information on this recall contact the firm at (949) 472-0006.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

HXX

Quantity affected

2,620 units

Distribution

Word wide Distribution: (USA) Nationwide including the states of CO, CT, FL, KY, LA, MA, NC, NY, OK, OR, TN, TX, VA, and WI; and the countries of Italy, Spain, Turkey, and the U.K.

Date initiated

2011-02-03

Date posted

2011-10-13

Date terminated

2013-02-05

Location

Irvine, CA