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

3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics… — recall Z-2844-2016

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

As described by U.S. FDA — Device Enforcement: 3.5mm Bowed Locking Compression Femur Plates, 18 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

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2844-2016
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
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Nationwide Distribution to AZ, CA, CO, DE, FL, GA, KY, MI, MN, MO, KY, RI, NY, OH, OR, RI, TN, TX, VA, WA Foreign: None VA/DOD: None
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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.

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