Z-2780-2017Class II

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...

Name: Z-2780-2017 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...
Creator: Ortho Solutions Inc
Published: 2017-04-19
License: https://open.fda.gov/license/

Ortho Solutions Inc / initiated 2017-04-19 / Terminated / root cause: labeling and UDI

FDA source

Ortho Solutions Inc began a recall of 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... on 2017-04-19. FDA classified it as Class II and gives the reason as "There is a material mislabeling of the AFN End Cap". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2780-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-19
Posted: 2017-07-28
Terminated: 2019-03-19
Recalling firm: Ortho Solutions Inc
Product: 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.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: There is a material mislabeling of the AFN End Cap.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Orthosol notified their customers on 4/19/2017 via USPS.
Quantity in commerce: 277 units
Distribution: US distribution to MD, NY & PA
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2780-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2780-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-07-28

Product code HSB

K121575Class IIOxford Ankle Fusion Nail(afn) SystemOrtho Solutions Limited / cleared 2012-09-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)