FDA Device recall Z-2386-2016
Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218
- FDA Device
- Class II
- terminated
- Published 2016-08-17
On 2016-08-17 the FDA classified a Class II recall of Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 by Integra Lifesciences, citing 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 s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2386-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-20 |
| Published | 2016-08-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Integra Lifesciences |
| Distribution | CO, DC, FL, IN, OK, VA |
Product
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.
Identifiers
| code_info | Lot # GT0420 and GT0419 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2386-2016%22
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