Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229
Reported: August 17, 2016 Initiated: July 20, 2016 #Z-2387-2016
Product Description
Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229
Reason for Recall
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.
Details
- Recalling Firm
- Integra LifeSciences Corp.
- Units Affected
- 111 units
- Distribution
- US Distribution to the states of : FL, VA, OK, CO, DC and IN.
- Location
- Plainsboro, NJ
Frequently Asked Questions
What product was recalled? ▼
Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229. Recalled by Integra LifeSciences Corp.. Units affected: 111 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 17, 2016. Severity: Moderate. Recall number: Z-2387-2016.
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