Integra External Fixation System Universal Wire Fixation Bolt — Class II medical device recall Z-2386-2016
Terminated recall by Integra LifeSciences Corp., reported 2016-08-17, distributed in CO, DC, FL, IN, OK, VA. Through the investigation of reported complaints Integra verified that there have been instances where the Uni
| Recall number | Z-2386-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2016-07-20 |
| Classified | 2016-08-11 |
| Reported by FDA | 2016-08-17 |
| Terminated | 2016-12-16 |
| Distributed | CO, DC, FL, IN, OK, VA |
| Quantity | 495 units |
| Lot numbers | GT0419, GT0420 |
| Model numbers | 12224218, 12224219 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2386-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.