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Recall Observatory FDA recall evidence

Device product

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 construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.

Z-2843-2016

July 27, 2016

Class II

Product summary

Firm
OrthoPediatrics Corp
Event
Event 74928
Status
Terminated
Classification
Class II
Quantity
41
Official record key
device-enforcement:Z-2843-2016

Official wording

Reason: 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.

Code information: Product Number: 00-1050-3214 Lot Number: NM02341 Product Number: 00-1050-3214 Lot Number: NM02342

Distribution pattern: 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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled