Z-0008-2012

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

Name: Z-0008-2012 OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho...
Creator: Osteomed, Lp
Published: 2011-06-07
License: https://open.fda.gov/license/

Osteomed / initiated 2011-06-07 / Terminated / root cause: design

FDA source

Osteomed, Lp began a recall of OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001 on 2011-06-07. The reason FDA records is "Two of the Implant Driver Assembly tips were reported to break during surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0008-2012
Status: Terminated
Initiated: 2011-06-07
Posted: 2011-10-04
Terminated: 2012-12-04
Recalling firm: Osteomed
Product: OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001
Product code: MRW System, Facet Screw Spinal Device
Reason for recall: Two of the Implant Driver Assembly tips were reported to break during surgery.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 20 units
Distribution: Nationwide Distribution including PA, TX, CA, IL IA, FL, CT, and MO
Product codes and lots: Part Number 800-1212 lot # 1038452.

Product code MRW

K102438UnclassifiedPrimalok Facet Fixation SystemOsteomed LP / cleared 2010-09-30

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)