CLASS II Device recall · Reported 9 Aug 2017 · FDA Enforcement Report
Oxford/Oxbridge AFN End Cap tp The end caps are a circular recalled
Ortho Solutions is recalling Oxford/Oxbridge AFN End Cap tp The end caps are a circular disk with a small threaded, distributed in Maryland, New York, Pennsylvania. The recall was initiated on 19 Apr 2017 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-2780-2017
- FDA event ID
- 77490
- Recalling firm
- Ortho Solutions, Mahwah, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Apr 2017
- FDA classified
- 28 Jul 2017
- Reported
- 9 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 19 Apr 2017 | Recall initiated by company | |
| 28 Jul 2017 | Classified by FDA | +100 days |
| 9 Aug 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a material mislabeling of the AFN End Cap.
Product as listed by the FDA
Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.
Where it was distributed
US distribution to MD, NY & PA
Questions about this recall
Why was it recalled?
There is a material mislabeling of the AFN End Cap.
Which lots are affected?
Item Code OS331107 S1009023 Mar-2017 S1009023 Mar-2017 Item Code OS331104 S1009020 Apr-2017 Item Code OS331100 995035 Aug-2017; Jan-2018 Item Code OS331100 S1212114 May-2018 Item Code OS331101 S1009017 Jun-2018 Item Code OS331103 S1009019 Oct-2018 Item Code OS331105 S1102004 Oct-2018 Item Code OS331100 S1307176 Nov-2018, Dec-2018 S1401116 Apr-2019 Item Code OS331103 S1009019 May-2019 Item Code OS331105 S1102004 May-2019 Item Code OOS331100 7802 Oct-2019
Where was it sold?
US distribution to MD, NY & PA
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 26 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 Ortho Solutions
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | System Part Numbers: OS900035-NS recalled by Ortho Solutions | Ortho Solutions | Other | |
| Device | CLASS II | FPS x non-locking screw recalled by Ortho Solutions | Ortho Solutions | Labeling Errors | NJ |
| Device | CLASS II | Ortho OS Solutions UltOS locking screw to Ortho Solutions recalled | Ortho Solutions | Device Malfunction | 9 states |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |