Z-0269-2010

Norian CRS Rotary Mixer Cement 10cc sterile

Name: Z-0269-2010 Norian CRS Rotary Mixer Cement 10cc sterile
Creator: Synthes USA (HQ), Inc.
Published: 2009-09-14
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2009-09-14 / Terminated / root cause: manufacturing process

FDA source

Synthes USA (HQ), Inc. began a recall of Norian CRS Rotary Mixer Cement 10cc sterile on 2009-09-14. The reason FDA records is "Non-conforming material - increased set time. Potential clinical ramifications associated with increased set time and decreased strength include extrusion of unset material and fragmentation of cured material. The risk...". 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-0269-2010
Status: Terminated
Initiated: 2009-09-14
Posted: 2009-11-16
Terminated: 2010-03-08
Recalling firm: Synthes GmbH
Product: Norian CRS Rotary Mixer Cement 10cc sterile
Product code: GXP Methyl Methacrylate For Cranioplasty
Reason for recall: Non-conforming material - increased set time. Potential clinical ramifications associated with increased set time and decreased strength include extrusion of unset material and fragmentation of cured material. The risk of Norian fragmentation post cure increases with a larger defect and a thicker layer of product. Customers were advised to call Synthes at 1-800-479-6329 to obtain a Return Autho
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm issued an Urgent Medical Device Recall letter dated 9/17/09 via USPS certified mail. The letter informed customers of the problem and the need to return the product. Sales Consultants that were shipped the device were notified by teleconference on 9/14/09. Consultants were instructed to go to their accounts to remove the product from inventory. Customers were advised to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Questions are directed to Synthes at 800-620-7025 x 5453 or 610-719-5453 or to your Synthes CMF Sales Consultant.
Quantity in commerce: 15 units
Distribution: The product was shipped to medical facilities in CO, KS, MA, MO, NY, SC, TX, UT, and WA.
Product codes and lots: Catalog number 614.10.01S. Lot number N996352

Product code GXP

K060445Class IINorian Crs Bone CementSynthes (Usa) / cleared 2006-04-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)