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 rate of 1mm/day. The patient may be instructed to turn the nuts 1/4 turn four times per day, accomplishing 0.25mm per 1/4 turn. The etched numbers offer reference points to the surgeon who instructs the patient on distraction technique.
This recall has been terminated (originally issued May 29, 2009).
- Company
- Synthes Spine
- Recall Initiated
- February 9, 2009
- Posted
- May 29, 2009
- Terminated
- December 15, 2009
- Recall Number
- Z-1324-2009
- Quantity
- 1,137 units
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Numbers are etched incorrectly on the product.
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.
Lot / Code Info
Lot Numbers: UR76230, US89403, US94671, US97826, 5674035, US90907, US94396 AND US97022.
Root Cause
Process control
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.