Norian CRS Rotary Mixer Cement 10cc sterile
FDA device recall Z-0269-2010 · posted 2009-11-16 · Terminated
Recall details
- Recalling firm
- Synthes USA (HQ), Inc.
- 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
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GXP
- Quantity affected
- 15 units
- Distribution
- The product was shipped to medical facilities in CO, KS, MA, MO, NY, SC, TX, UT, and WA.
- Date initiated
- 2009-09-14
- Date posted
- 2009-11-16
- Date terminated
- 2010-03-08
- Location
- West Chester, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NORIAN CRS BONE CEMENT (K060445) | Synthes (Usa) | 2006-04-13 |