PANTA Nails, 10mm x 150 length, Newdeal, Lyon France; Integra, 311 Enterprise Drive, Plainsboro, NJ. The Newdeal Ankle N
FDA device recall Z-1877-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- Certain PANTA Nails from one lot were incorrectly manufactured. The internal thread for certain PANTA Nails (Part Number 500050ND; Lot Number: E7XX) may present an insufficient depth and may not allow the engagement of the threaded part of the compression device. The risks presented include: an increase in surgery time, or the implantation of a nail less ideally suited for the patient's anatomy
- Action taken
- On March 24, 2008, Recall Notification Letters and Recall Acknowledgement Forms were sent to all Integra Sales Specialists to confirm products currently in their inventory and to place inventory on hold with no further shipments to customers. If you have any questions contact Judy O'Grady at (609) 936-2311.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 45 units received in US, 22 were distributed.
- Distribution
- Class II Recall - Nationwide Distribution.
- Date initiated
- 2008-03-24
- Date posted
- 2008-09-16
- Date terminated
- 2008-09-16
- Location
- Plainsboro, NJ
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 |