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

Recall Z-2843-2016 — 3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a const

U.S. FDA — Device Enforcement · United States · 2016-07-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2843-2016
Date of alert: 2016-07-27
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: OrthoPediatrics Corp
Product category: device
Product type: Devices

Reported risk: OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled.

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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