Z-0968-2009

NFlex Stabilization System 150 mm, Catalog number NF60150-1. spinal fusion surgery

Name: Z-0968-2009 NFlex Stabilization System 150 mm, Catalog number NF60150-1. spinal fusion surgery
Creator: Synthes Spine
Published: 2008-11-07
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2008-11-07 / Terminated / root cause: manufacturing process

FDA source

Synthes Spine began a recall of NFlex Stabilization System 150 mm, Catalog number NF60150-1. spinal fusion surgery on 2008-11-07. The reason FDA records is "the dimensional specifications are incorrect". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0968-2009
Status: Terminated
Initiated: 2008-11-07
Posted: 2009-02-03
Terminated: 2009-10-05
Recalling firm: Synthes GmbH
Product: NFlex Stabilization System 150 mm, Catalog number NF60150-1. spinal fusion surgery
Product code: NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr
Reason for recall: the dimensional specifications are incorrect
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm issued an e-mail on 11/18/08 to their sales force to inform them of the problem and the need to remove the product.The recalling firm issued Medical Device recall letters dated 11/19/08 to their customers to inform them of the problem and the need to return the product. Contact Synthes at 800-620-7025 ext. 7025 or 610-719-5750 for additional information.
Quantity in commerce: 1508 (total)
Distribution: Worldwide: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: Germany, Denmark, Switzerland, and Korea.
Product codes and lots: lot numbers P07M01 exp 12/31/08; P07M03 exp 12/31/08; P06H01 exp 8/31/07; P06M01 exp 12/31/07; and P06J01 exp 9/30/07

Product code NPQ

K072685Class IINgarde SystemN Spine, Inc. / cleared 2007-10-19

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)