Recall Z-2843-2016 ยท HWC Screw, Fixation, Bone
OrthoPediatrics Corp
3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduct
| Date | Sep 19, 2016 (initiated Jul 27, 2016) |
| Status | Terminated |
| Reason | OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled. |
| Root cause | Labeling mix-ups |
| Action | Orthopediatrics initiated the recall of 3.5mm Bowed Locking Compression Femur Plates by distributing e-mails on 0July 27, 2016, followed by telephone calls to all customers on July 28, 2016. All distributors and direct representatives were sent an e-mail to provide them with a written notification of the voluntary recall and instruct them to quarantine all identified devices from the affected lot numbers immediately. Customers were instructed to quarantine recalled product and response via a hard copy Reply Form that was included in a hard copy of the Recall Notice. Each sales representati |
| Quantity | 41 |
| Distribution | Nationwide Distribution to AZ, CA, CO, DE, FL, GA, KY, MI, MN, MO, KY, RI, NY, OH, OR, RI, TN, TX, VA, WA Foreign: None VA/DOD: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083286 | ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM OrthoPediatrics Corp., Jan 30, 2009 |