Z-2718-2011

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

Name: Z-2718-2011 PERPOS PLS SYSTEM, CATALOG NO. 9045-01 A sterile, medical device kit consisting of the components listed in...
Creator: Interventional Spine Inc
Published: 2011-03-23
License: https://open.fda.gov/license/

Interventional Spine, Inc. / initiated 2011-03-23 / Terminated

FDA source

Interventional Spine Inc began a recall of PERPOS PLS SYSTEM, CATALOG NO. 9045-01 A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical... on 2011-03-23. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2718-2011
Status: Terminated
Initiated: 2011-03-23
Posted: 2011-07-01
Terminated: 2013-02-14
Recalling firm: Interventional Spine, Inc.
Product: PERPOS PLS SYSTEM, CATALOG NO. 9045-01 A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints. A Surgical Technique brochure is provided in Appendix A and other labeling, including instructions for use, is provided in Appendix B.
Product code: HXI Passer, Wire, Orthopedic
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
FDA root cause: Pending
Action: 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
Quantity in commerce: 864 units total for all products
Distribution: Nationwide Distribution including the states of to NC, NY, TN & VA
Product codes and lots: LOT #'s: 040309-A, 041409-A

Product code HXI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)