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.
Hazard
The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.
What You Should Do
Remedy
On 15-June-2012, a follow-up, URGENT Recall of MIS-BRANDED PediLoc Locking Plate e-mail was sent to all Distributors and direct representatives to provide them with a written notification of the voluntary recall. The e-mail identified the affected product and the reason for the recall. It also instructed them to quarantine all identified devices from the affected lot number immediately. A certified Voluntary Recall notice was also sent as a follow up along with a return prepaid pouch for the return of the recalled device(s) and Mandatory Reply Form.
Affected by this recall?
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Products
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.
- Brand
- OrthoPediatrics Corp
- UPC
- Lot number: 7736703 and part number: 00-1050-4308
Units Affected
15 devices