PERPOS PLS SYSTEM, CATALOG NO. 9045-01 A sterile, medical device kit consisting of the components listed in Table 1-1 be

FDA device recall Z-2718-2011 · posted 2011-07-01 · Terminated

Recall details

Recalling firm

Interventional Spine Inc

Reason for recall

This recall has been initiated due to K-wires with a distal tip diameter that may be greater than specified causing an interference fit with the canulated screw. Removing the K-wire during a procedure may dislocate the implant resulting in the implant loosening or being pulled out or position. Use of this product may result in a delay of the surgical procedure and/or pull-out of the facet screw

Action taken

Interventional Spine sent an RECALL NOTIFICATION letter dated March 23, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. The customer was instructed to take the following actions: Immediately examine inventory and quarantine product subject to recall. In addition, if this product was further distributed, please notify the Vice President Quality Assurance at once. Consignee were asked to also complete and return the enclosed response form as soon as possible. Consignee with questions were directed to the Consignees' Regional Director or the Vice President Quality Assurance. For further questions, please call (949) 472-0006

Root cause

Pending

Status

Terminated

Product code

HXI

Quantity affected

864 units total for all products

Distribution

Nationwide Distribution including the states of to NC, NY, TN & VA

Date initiated

2011-03-23

Date posted

2011-07-01

Date terminated

2013-02-14

Location

Irvine, CA