Synthes USA HQ, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0277-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: Stabilization of soft tissues and fractures; Polytrauma/multiple orthopedic trauma; Vertically stable pelvic fractures, or as treatment adjunct for vertically unstable pelvic fractures; Arthrodeses and osteotomies with soft tissue problems - failures of total joints; Neutralization of fractures stabilized with limited internal fixation; Non-unions/septic non-unions; Intra-operative reductions/stabilization tool to assist with indirect reduction; and Unilateral rectilinear bone segment transport or leg lengthening.

Product Classification:

Class II

Date Initiated: September 28, 2012

Date Posted: November 21, 2012

Recall Number: Z-0277-2013

Event ID: 63446

Reason for Recall:

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.

Status: Terminated

Product Quantity: 8

Code Information:

Part number 390.007, Lot number 6800599

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated