Z-2057-2012 Class II Terminated
FDA device recall Z-2057-2012 was initiated by OrthoPediatrics Corp on Jun 14, 2012 and is designated Class II. Reason for recall: The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device. The recall status is terminated (terminated Apr 30, 2013). Affected quantity: 15 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 1, 2012
- Initiation Date
- Jun 14, 2012
- Termination Date
- Apr 30, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 devices
Product Description
OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures.
Reason for Recall
The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.
Distribution Pattern
Worldwide Distribution -- USA, including states of IN, GA, MI, FL, MO, OH, and SC and country of Australia.
Code Information
Lot number: 7736703 and part number: 00-1050-4308
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2057-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026