Recall Z-2057-2012 ยท HRS Plate, Fixation, Bone
OrthoPediatrics Corp
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.
| Date | Jul 20, 2012 (initiated Jun 14, 2012) |
| Status | Terminated |
| Reason | The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device. |
| Root cause | Error in labeling |
| Action | 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. |
| Quantity | 15 devices |
| Distribution | Worldwide Distribution -- USA, including states of IN, GA, MI, FL, MO, OH, and SC and country of Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083286 | ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM OrthoPediatrics Corp., Jan 30, 2009 |