Synthes USA HQ, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1816-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.

Product Classification:

Class II

Date Initiated: October 12, 2012

Date Posted: August 7, 2013

Recall Number: Z-1816-2013

Event ID: 65669

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 8

Code Information:

Part Number 390.007, Lot Number 6800599

Distribution Pattern:

US Distribution including the states of CA, MN, NC and TN.

Voluntary or Mandated:

Voluntary: Firm initiated