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Square Nut MR Safe, Catalog Number 03.311.060 recallZ-1324-2009 · Synthes Spine · initiated Feb 9, 2009

Terminated All recalls posted in May 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Synthes Spine or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Numbers are etched incorrectly on the product.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-1324-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 9, 2009
Posted by the FDA
May 29, 2009
Recalling firm
Synthes Spine
Quantity
1,137 units
Product code
KTT
FDA submissions
K051600
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.

Product description

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.

Code information (models, lots, serial numbers)

Lot Numbers: UR76230, US89403, US94671, US97826, 5674035, US90907, US94396 AND US97022.

Other devices under the same FDA submission

10 devices cleared under K051600 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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