Recall Z-0432-2013 ยท HRS Plate, Fixation, Bone
OrthoPediatrics Corp
4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock Extension Osteotomy Plate ( PLEO ). The product included in this recall is a Class I, 4.5mm PLEO Osteotomy Guide Instrument, common name: Guide, Surgical, Instrument. The PediLoc Extension Osteotomy Plate is part of the
| Date | Nov 22, 2012 (initiated Oct 18, 2012) |
| Status | Terminated |
| Reason | Complaint received from sales representative that the drill guide tubes would not screw into replenishment instrument. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended. |
| Root cause | Nonconforming Material/Component |
| Action | OrthoPediatrics sent an "URGENT RECALL" e-mail of the Trochar Scalpel Instrument to all affected customers. The e-mail identifies the product, problem, and actions to be taken by the customers. The e-mail states that the instrument has been manufactured incorrectly and will not work (function as intended). The threads in the instrument are faulty and the guide tubes will not thread in correctly. Customers will receive follow up information. |
| Quantity | 24 |
| Distribution | Nationwide Distribution-including the states of OH, NC, CO, FL, IN, MI, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083286 | ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM OrthoPediatrics Corp., Jan 30, 2009 |