4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This syste
FDA device recall Z-0432-2013 · posted 2012-11-22 · Terminated
Recall details
- Recalling firm
- OrthoPediatrics Corp
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 24
- Distribution
- Nationwide Distribution-including the states of OH, NC, CO, FL, IN, MI, and TX.
- Date initiated
- 2012-10-18
- Date posted
- 2012-11-22
- Date terminated
- 2013-09-18
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM (K083286) | OrthoPediatrics Corp. | 2009-01-30 |