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.
- Company
- Orthopediatrics Corp
- Recall Initiated
- June 14, 2012
- Posted
- July 20, 2012
- Terminated
- April 30, 2013
- Recall Number
- Z-2057-2012
- Quantity
- 15 devices
- Firm Location
- Warsaw, IN
Reason for Recall
The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.
Distribution
Worldwide Distribution -- USA, including states of IN, GA, MI, FL, MO, OH, and SC and country of Australia.
Lot / Code Info
Lot number: 7736703 and part number: 00-1050-4308
Root Cause
Error in labeling
Action Taken
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.