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U.S. Department of Health and Human Services

Class 2 Device Recall BONELOK PLS Implant

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  Class 2 Device Recall BONELOK PLS Implant see related information
Date Initiated by Firm March 15, 2011
Date Posted August 18, 2011
Recall Status1 Terminated 3 on February 11, 2013
Recall Number Z-3034-2011
Recall Event ID 58381
510(K)Number K043351  
Product Classification System, facet screw spinal device - Product Code MRW
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.
Code Information 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
Recalling Firm/
Interventional Spine Inc
13700 Alton Pkwy Ste 160
Irvine CA 92618-1618
For Additional Information Contact
Manufacturer 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 Determined
Cause 2
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MRW and Original Applicant = TRIAGE MEDICAL INC