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

Recall Z-1534-2013 — 90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications in

U.S. FDA — Device Enforcement · United States · 2013-04-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1534-2013
Date of alert: 2013-04-19
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: OrthoPediatrics Corp
Product category: device
Product type: Devices

Reported risk: Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.

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.

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