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

Recall Z-0408-2014 — Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck fractures, intercondylar femur fractures and sacroiliac joint disruptions.

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-0408-2014
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: There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to break during surgery.

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

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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.

Recall Z-0408-2014 — Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck fractures, intercondylar femur fractures and sacroiliac joint disruptions.

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