Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices
FDA device recall Z-0207-2013 · posted 2012-11-05 · Terminated
Recall details
- Recalling firm
- OrthoPediatrics Corp
- Reason for recall
- A complaint received from sales representative that a replenishment instrument was too short. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.
- Action taken
- OrthoPediatrics Corp sent an Urgent Recall e-mail dated September 14, 2012, to all affected customers. The e-mail identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine all identified devices from the affected lot numbers immediately. Customers were also asked to complete the Mandatory Reply Form. Customers with questions should call 574-268-6379.
- Root cause
- Reprocessing Controls
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 78
- Distribution
- Nationwide Distribution including AL, IL, NY, FL, TX, MI, KY, NC, CO, and GA.
- Date initiated
- 2012-09-13
- Date posted
- 2012-11-05
- 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 |
|---|---|---|
| CDS 3-PD HEMATOLOGY CONTROLS (K024173) | Clinical Diagnostic Solutions, Inc. | 2003-01-14 |