Z-2348-2010

NFlex Stabilization System 150mm The Synthes N-Hance and NFix II rods are intended to provide immobilization...

Name: Z-2348-2010 NFlex Stabilization System 150mm The Synthes N-Hance and NFix II rods are intended to provide immobilization...
Creator: Synthes USA (HQ), Inc.
Published: 2009-02-09
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2009-02-09 / Terminated / root cause: manufacturing process

FDA source

Synthes USA (HQ), Inc. began a recall of NFlex Stabilization System 150mm The Synthes N-Hance and NFix II rods are intended to provide immobilization and stabilization of spinal segments as an adjunct... on 2009-02-09. The reason FDA records is "package integrity compromised". 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-2348-2010
Status: Terminated
Initiated: 2009-02-09
Posted: 2010-09-01
Terminated: 2010-09-15
Recalling firm: Synthes GmbH
Product: NFlex Stabilization System 150mm The Synthes N-Hance and NFix II rods are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine.
Product code: NQP Posterior Metal/Polymer Spinal System, Fusion
Reason for recall: package integrity compromised
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: The firm, SYNTHES, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated February 9, 2009 and an updated letter dated February 12, 2009, with updated expiration information to customers. The letters described the product, problem and action to be taken by customer. The customers were instructed to call Synthes at 1-800-479-6329 if they have any of the identified devices to obtain a Return Authorization Number; complete the enclosed Verification Section attachment and return this letter with the recalled product to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If they do not have the identified product ,complete the Verification Section attachment and return the document to Synthes by Fax 610-719-5120 or scan/email: [email protected]. If you have any questions, please call 800-620-7025 x 5454 or 610-719-5454 or contact your Synthes Spine Sales Consultant.
Distribution: Worldwide distribution: USA including states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NM, NV, NY, OH, OR, PA, SC, TN , TX, UT, VA, WA, WI, and WV and countries including Denmark, Germany, Korea and Switzerland.
Product codes and lots: Catalog number NF60150-1. Lot numbers: P06H01, P06J01, P06M01, P07H02, P07J02, and P07M03

Product code NQP

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)