OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison,

FDA device recall Z-0008-2012 · posted 2011-10-04 · Terminated

Recall details

Recalling firm

Osteomed, Lp

Reason for recall

Two of the Implant Driver Assembly tips were reported to break during surgery.

Action taken

OsteoMed LP sent an Urgent --Product Recall letter dated June 7, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately for affected inventory and promptly return any affected inventory to: OsteoMed LP Attan: Rebecca Ellis 3885 Arapaho Road Addison, Texas 75001 If the customer further distributed any of the affected product customers were instructed to immediately contact their accounts and advise them of the recall situation and have them return any devices they may have to OsteoMed at the above address. Customers were asked to complete and return the enclosed response immediately in the enclosed, postage paid envelope even if they do not have the device. For any questions please call (800) 456-7779.

Root cause

Device Design

Status

Terminated

Product code

MRW

Quantity affected

20 units

Distribution

Nationwide Distribution including PA, TX, CA, IL IA, FL, CT, and MO

Date initiated

2011-06-07

Date posted

2011-10-04

Date terminated

2012-12-04

Location

Addison, TX

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