Z-1324-2009

Square Nut MR Safe, Catalog Number 03.311.060. The Square Nut MR Safe is used in conjunction with Synthes...

Name: Z-1324-2009 Square Nut MR Safe, Catalog Number 03.311.060. The Square Nut MR Safe is used in conjunction with Synthes...
Creator: Synthes Spine
Published: 2009-02-09
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2009-02-09 / Terminated / root cause: manufacturing process

FDA source

Synthes Spine began a recall of 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... on 2009-02-09. The reason FDA records is "Numbers are etched incorrectly on the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1324-2009
Status: Terminated
Initiated: 2009-02-09
Posted: 2009-05-29
Terminated: 2009-12-15
Recalling firm: Synthes GmbH
Product: 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.
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Reason for recall: Numbers are etched incorrectly on the product.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Lot Numbers: UR76230, US89403, US94671, US97826, 5674035, US90907, US94396 AND US97022.

Product code KTT

K051600Class IISynthes (USA) Distraction Osteogenesis SystemSynthes (Usa) / cleared 2005-07-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)