Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0388-2014 — 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 s

U.S. FDA — Device Enforcement · United States · 2013-07-31 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0388-2014
Date of alert: 2013-07-31
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Synthes USA HQ, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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