90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade
FDA device recall Z-1536-2013 · posted 2013-06-12 · Terminated
Recall details
- Recalling firm
- OrthoPediatrics Corp
- Reason for recall
- Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.
- Action taken
- OrthoPediatrics sent an Urgent Voluntary Recall notifiation via telephone and email to all affected consignees. The letter instructed consignees to take possession of any affected devices and quarantine immediately. A Mandatory Reply Form is included with the notification letter to be completed and returned. Please contact Greg Teghtmeyer if you have any questions (574-268-6379).
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 130 devices were shipped
- Distribution
- USA Nationwide Distribution
- Date initiated
- 2013-04-19
- Date posted
- 2013-06-12
- Date terminated
- 2013-09-19
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ORTHOPEDIATRICS BLADE PLATE SYSTEM (K110959) | OrthoPediatrics Corp. | 2011-08-05 |