FDA Device recall Z-2387-2016
Integra External Fixation System Slotted Post - Small Catalogue #12224228
- 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 Slotted Post - Small Catalogue #12224228 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-2387-2016 |
| 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 Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229
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 # QJ0139, QJ0148, QJ0140, QJ0149, QJ0287 |
|---|
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-2387-2016%22
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