FDA Device recall Z-0388-2014

Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthro…

• FDA Device
• Class II
• terminated
• Published 2013-12-04

On 2013-12-04 the FDA classified a Class II recall of Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthro… by Synthes Usa Hq, citing all lots of the Synthes Tensioning Device were recalled due to the potential for the reaction fork to come loose from the main body of the device and not allow the wire to release….

Read the official FDA Device notice

Product

Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.

Reason

All lots of the Synthes Tensioning Device were recalled due to the potential for the reaction fork to come loose from the main body of the device and not allow the wire to release, nor the device to apply tension.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0388-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.