OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pedia
FDA device recall Z-2057-2012 · posted 2012-07-20 · Terminated
Recall details
- Recalling firm
- OrthoPediatrics Corp
- Reason for recall
- The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.
- Action taken
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 15 devices
- Distribution
- Worldwide Distribution -- USA, including states of IN, GA, MI, FL, MO, OH, and SC and country of Australia.
- Date initiated
- 2012-06-14
- Date posted
- 2012-07-20
- Date terminated
- 2013-04-30
- 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 |