Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK082650	Date18 Nov 2008Cleared	StatusActive

Coverage

1 jurisdiction

United States — FDA 510(k) Active

5 recalls · 1 ongoing · FDA

- Ongoing Z-1816-2013 FDA Class II initiated 12 Oct 2012
It was discovered internally that there was a discrepancy between the insert provided with the Tube to Tube Clamp and what was called for in the Bill of Materials. Following a detailed investigation, it was determined that the incorrect insert was used which indicates that the device is MR Safe, when it is actually MR Conditional.
- Terminated Z-2451-2015 FDA Class II initiated 29 Jul 2015
Labeling changes were made related to MR conditions that align with standard definitions for MR Safe, MR Conditional, and MR Unsafe. This recall identifies additional Trauma External Fixation System part numbers that should be considered MR Conditional. One serious injury reported.
- Terminated Z-1833-2014 FDA Class II initiated 10 Apr 2014
Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe.
- Terminated Z-0941-2013 FDA Class II initiated 11 Jan 2013
The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts.
- Terminated Z-0277-2013 FDA Class II initiated 28 Sep 2012
The insert provided with the product for the specific lot number indicates that this product is MR safe. This product is MR Conditional and is etched as MR Conditional. The insert is incorrect.

510(k)