Square Nut MR Safe, Catalog Number 03.311.060. The Square Nut MR Safe is used in conjunction with Synthes Distraction Os
FDA device recall Z-1324-2009 · posted 2009-05-29 · Terminated
Recall details
- Recalling firm
- Synthes Spine
- Reason for recall
- Numbers are etched incorrectly on the product.
- Action taken
- An "Urgent: Medical Device Recall" letter dated February 6, 2009 was sent to all affected Synthes Trauma Sales Consultants via USPS certified mail on February 09, 2009 and affected In House employees were notified via return receipt email on February 09, 2009. All affected hospitals were notified of the recall through a notification letter mailed via USPS certified mail on February 09, 2009. The notification letter described the affected product, issue and actions for recipients. Direct questions about the recall to Synthes Spine by calling 800-620-7025, Extension 5455 or 610-719-5455.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KTT
- Quantity affected
- 1,137 units
- Distribution
- Worldwide Distribution -- US (states of AR, CA, CO, CT, FL, IA, IL, LA, MD, ME, MI, MN, MS, NJ, NY, OK, PA, SC, TX, and UT) and country of Switzerland.
- Date initiated
- 2009-02-09
- Date posted
- 2009-05-29
- Date terminated
- 2009-12-15
- 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 |
|---|---|---|
| SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM (K051600) | Synthes (Usa) | 2005-07-27 |