—#85637

Product

Norian CRS Rotary Mixer Cement 10cc sterile

FDA product code: GXP — Methyl Methacrylate For Cranioplasty
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K060445
Affected lot / code info: Catalog number 614.10.01S. Lot number N996352

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Synthes USA (HQ), Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern: The product was shipped to medical facilities in CO, KS, MA, MO, NY, SC, TX, UT, and WA.

Timeline

Recall initiated: 2009-09-14
Posted by FDA: 2009-11-16
Terminated: 2010-03-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85637. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.