Panta Support Device Panta Arthrodesis Nail Instrumentation Tray One unit per package. The PANTA(R) Nail is intended for
FDA device recall Z-0308-2011 · posted 2010-11-02 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corporation
- Reason for recall
- Inability to properly align the calcaneal screw placement on a consistent basis, due to a manufacturing defect of of the targeting frame (Panta Support Device).
- Action taken
- OIntegra issued Urgent Product Recall Notification letters dated 3/1/2010 to customers and distributors to notify them of the problem. Customers were requested to check their inventory to determine if they have an of the affected devices. If so, custo0mers should stop using the product. Custoemrs with the affected product should contact their local Sales Representative for assistance, or contact Integra at 800-654-2873 - 3 to obtain a returned material authorization number, and return the product to their local representative. All customers were requested to complete and return a Recall Acknowledgement and Return Form..
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 108 Units
- Distribution
- Worldwide distribution: USA including states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, UT, VA, WA and WI; and countries of:
- Date initiated
- 2010-03-01
- Date posted
- 2010-11-02
- Date terminated
- 2012-02-16
- Location
- Cincinnati, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEWDEAL ANKLE NAIL (K050882) | New Deal, S.A. | 2005-05-27 |