CLASS II Device recall · Reported 17 Aug 2016 · FDA Enforcement Report
Integra External Fixation System Slotted Post - Small recalled
Integra LifeSciences is recalling Integra External Fixation System Slotted Post - Small, distributed in Colorado, District of Columbia, Florida, Indiana, Oklahoma, Virginia. The recall was initiated on 20 Jul 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2387-2016
- FDA event ID
- 74757
- Recalling firm
- Integra LifeSciences, Plainsboro, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Jul 2016
- FDA classified
- 11 Aug 2016
- Reported
- 17 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 Jul 2016 | Recall initiated by company | |
| 11 Aug 2016 | Classified by FDA | +22 days |
| 17 Aug 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229
Where it was distributed
US Distribution to the states of : FL, VA, OK, CO, DC and IN.
Questions about this recall
Is Integra External Fixation System Slotted Post - Small recalled?
Yes. Integra LifeSciences recalled Integra External Fixation System Slotted Post - Small on 20 Jul 2016. The recall is Class II and its status is Terminated. Recall number Z-2387-2016.
Why was it 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 lots are affected?
Lot # QJ0139, QJ0148, QJ0140, QJ0149, QJ0287
Where was it sold?
US Distribution to the states of : FL, VA, OK, CO, DC and IN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Integra LifeSciences
All 246| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Aurora Surgiscope System, Sterile recalled by Integra LifeSciences | Integra LifeSciences | Sterility | Nationwide |
| Device | CLASS II | MediHoney¿ Gel MediHoney¿ Wound & Burn Dressing Gel recalled | Integra LifeSciences | Packaging Defects | Nationwide |
| Device | CLASS II | Codman Certas Plus Programmable Valve Inline Small Valve Only recalled | Integra LifeSciences | Packaging Defects | Nationwide |
| Device | CLASS II | Codman Certas Plus Programmable Valve Right Angle Valve Only recalled | Integra LifeSciences | Packaging Defects | Nationwide |
| Device | CLASS II | Codman Certas Plus Programmable Valve Inline Small Valve Only recalled | Integra LifeSciences | Packaging Defects | Nationwide |
Other Other Medical Devices recalls
All 13,771| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ortho Aspiration Kit recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Arterial Line Insertion Kit recalled | Medline Industries | Sterility | Nationwide |