Synthes USA (HQ), Inc. Norian CRS Rotary Mixer Cement 10cc sterile Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Norian CRS Rotary Mixer Cement 10cc sterile
Brand
Synthes USA (HQ), Inc.
Lot Codes / Batch Numbers
Catalog number 614.10.01S. Lot number N996352
Products Sold
Catalog number 614.10.01S. Lot number N996352
Synthes USA (HQ), Inc. is recalling Norian CRS Rotary Mixer Cement 10cc sterile due to Non-conforming material - increased set time. Potential clinical ramifications associated with increased set time and decreased strength include extr. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CO, IN, KS, MA, MO, NY, SC, TX, UT, WA
Page updated: Jan 10, 2026