FDA Enforcement
Class II
Terminated
Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal Wire Fixation Bolt - 23 mm Catalogue #12224219
Recall: Z-2386-2016
·
Reported August 17, 2016
Enforcement
- Recall Number
- Z-2386-2016
- Event ID
- 74757
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Integra LifeSciences Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 17, 2016
- Initiation Date
- July 20, 2016
- Classification Date
- August 11, 2016
- Termination Date
- December 16, 2016
- Address
- 311 Enterprise Dr, Plainsboro, NJ, 08536-3344, United States
Description
Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal Wire Fixation Bolt - 23 mm Catalogue #12224219
Reason
Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical site.
Code Info
Lot # GT0420 and GT0419
Distribution
US Distribution to the states of : FL, VA, OK, CO, DC and IN.
Quantity
495 units