Recall Z-2057-2012— OrthoPediatrics Corp
Class II · Terminated
Class II FDA medical device recall by OrthoPediatrics Corp, initiated 2012-06-14, terminated 2013-04-30. It names one FDA 510(k) clearance: K083286. Product: 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: The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device..
- Recalling firm
- OrthoPediatrics Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-06-14
- Terminated
- 2013-04-30
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.