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

FDA device recall Z-3034-2011 · posted 2011-08-18 · Terminated

Recall details

Recalling firm

Interventional Spine Inc

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

MRW

Quantity affected

407 units

Distribution

Nationwide Distribution including CO, CT, FL, KY, LA, MA, MO, NC, NY, OK, OR, TN, TX, VA & WI

Date initiated

2011-03-15

Date posted

2011-08-18

Date terminated

2013-02-11

Location

Irvine, CA

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