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.
Reported: August 1, 2012 Initiated: June 14, 2012 #Z-2057-2012
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.
Details
- Recalling Firm
- OrthoPediatrics Corp
- Units Affected
- 15 devices
- Distribution
- Worldwide Distribution -- USA, including states of IN, GA, MI, FL, MO, OH, and SC and country of Australia.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by OrthoPediatrics Corp. Units affected: 15 devices.
Why was this product recalled? ▼
The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 1, 2012. Severity: Moderate. Recall number: Z-2057-2012.
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