Z-3034-2011

Catalog # 9024-00 or LSW-S-3040 for 4.5mm BONE-LOK PLS Implant A sterile, canulated screw that is supplied as...

Name: Z-3034-2011 Catalog # 9024-00 or LSW-S-3040 for 4.5mm BONE-LOK PLS Implant A sterile, canulated screw that is supplied as...
Creator: Interventional Spine Inc
Published: 2011-03-15
License: https://open.fda.gov/license/

Interventional Spine, Inc. / initiated 2011-03-15 / Terminated

FDA source

Interventional Spine Inc began a recall of Catalog # 9024-00 or LSW-S-3040 for 4.5mm BONE-LOK PLS Implant A sterile, canulated screw that is supplied as a stand-alone product. The 4.5mm BONE-LOK PLS... on 2011-03-15. The reason FDA records is "This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the compression step, requiring that compression be completed with a device driver rather than the compression tool. Use of...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3034-2011
Status: Terminated
Initiated: 2011-03-15
Posted: 2011-08-18
Terminated: 2013-02-11
Recalling firm: Interventional Spine, Inc.
Product: Catalog # 9024-00 or LSW-S-3040 for 4.5mm BONE-LOK PLS Implant A sterile, canulated screw that is supplied as a stand-alone product. The 4.5mm BONE-LOK PLS Implant is also supplied as a component of the Single Use PERPOS PLS System (9045-01 and 9045-02). The labeling and instructions for use for the 4.5mm BONE-LOK PLS a Implant (9024-00) are provided in Appendix C.
Product code: MRW System, Facet Screw Spinal Device
Reason for recall: This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the compression step, requiring that compression be completed with a device driver rather than the compression tool. Use of this product may result in less than optimal compression leading to pseudoarthrosis, non-union or facet pain.
FDA root cause: Other
Action: Interventional Spine, Inc. sent a recall letter dated March 15, 2011, informing consignees of the product, the problem, and the action to be taken. Consignees were asked to immediately examine their inventory and quarantine product subject to recall. In addition, if they distributed the product further they were asked to notify Jane Metcalf, the Vice President of Quality Assurance at once. Interventional Spine further informed consignees that the recall was being carried out to the individual consignee level. And their assistance was appreciated and necessary to prevent use of this product. They were then asked to complete and return the enclosed response form as soon as possible. Questions were directed to call their regional directors. For questions regarding this recall call 949-472-0006.
Quantity in commerce: 407 units
Distribution: Nationwide Distribution including CO, CT, FL, KY, LA, MA, MO, NC, NY, OK, OR, TN, TX, VA & WI
Product codes and lots: CATALOG NO. 9045-01, LOT #'s: 050709-8, 050809-C, 051209-D, 060209-A, 060809-C, 061709-C, 062009-0, CATALOG NO. 9045-02, LOT #'s: 050809-B, 051309-8,060809-8, 061 709-0,060209-A

Product code MRW

K043351Unclassified4.5Mm Bone-Lok Facet Screw, Models Tfcd-45-3040S or N; Sfcd-45-3040S or NTriage Medical, Inc. / cleared 2005-02-18

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)