Recall Z-1324-2009 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Synthes Spine
Square Nut MR Safe, Catalog Number 03.311.060. The Square Nut MR Safe is used in conjunction with Synthes Distraction Osteogenesis Ring Systems. It can be used to secure components together or as a means of bone distraction/compression. Each side of the Square Nut is etched with a number, 1-2-3-4, which can be referenced during distraction/compression. Distraction of bone typically occurs a a ra
| Date | May 29, 2009 (initiated Feb 9, 2009) |
| Status | Terminated |
| Reason | Numbers are etched incorrectly on the product. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051600 | SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM Synthes (Usa), Jul 27, 2005 |