Recall Z-0269-2010 ยท GXP Methyl Methacrylate For Cranioplasty
Synthes USA (HQ), Inc.
Norian CRS Rotary Mixer Cement 10cc sterile
| Date | Nov 16, 2009 (initiated Sep 14, 2009) |
| Status | Terminated |
| Reason | 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 | 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 | 15 units |
| Distribution | The product was shipped to medical facilities in CO, KS, MA, MO, NY, SC, TX, UT, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060445 | NORIAN CRS BONE CEMENT Synthes (Usa), Apr 13, 2006 |