Norian CRS Rotary Mixer Cement 10cc sterile
Recall
- Recall Number
- Z-0269-2010
- Event Number
- 53496
- Firm
- Synthes USA (HQ), Inc.
- FEI Number
- 3005180112
- Product Code
- GXP
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- September 14, 2009
- Posted
- November 16, 2009
- Terminated
- March 8, 2010
- Address
- 1302 Wrights Ln E, West Chester, PA, 19380-3417
Description
Norian CRS Rotary Mixer Cement 10cc sterile
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
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.
The product was shipped to medical facilities in CO, KS, MA, MO, NY, SC, TX, UT, and WA.
15 units