Ortho Solutions Recalls Mislabelled Oxford AFN End Caps
Ortho Solutions Inc is recalling 277 units of Oxford/Oxbridge AFN End Caps due to material mislabeling. The affected devices were distributed to Maryland, New York, and Pennsylvania.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text identifies the issue as 'material mislabeling' without reporting any illnesses or injuries. This aligns with the rubric for moderate severity involving labeling errors.
Plain-English summary
Ortho Solutions Inc is recalling 277 units of Oxford/Oxbridge AFN End Caps. These medical devices are circular disks with a small threaded shaft designed to be screwed to the distal end of a nail. The recall is being conducted because of a material mislabeling issue with the product.
The affected end caps were distributed in the United States to Maryland, New York, and Pennsylvania. The recall covers multiple item codes and lot numbers manufactured between March 2017 and October 2019.
Consumers and healthcare providers should stop using the affected end caps and contact Ortho Solutions Inc for further instructions on how to return or dispose of the devices.
The recalled product
- 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.
- Manufacturer
- Ortho Solutions Inc
- Hazard
- Affected units
- 277
Distribution
Related recalls
Same manufacturer · Ortho Solutions Inc
See all →- ModerateOrtho Solutions Recalls Mislabeled 35mm Non-Locking Orthopedic Screws
FDA (Devices) · 2016-09-28
- HighOrtho Solutions Recalls UltOS 3.5mm Locking Screws Due to Manufacturing Defect
FDA (Devices) · 2015-10-14
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
Similar recalls
- ModerateOrtho Solutions Recalls Mislabeled 35mm Non-Locking Orthopedic Screws
FDA (Devices) · 2016-09-28
- ModerateOlympus Recalls Mislabeled Smart Stapes Protheses Piston Medical Devices
FDA (Devices) · 2020-08-26
- ModerateOMNI Hip System Acetabular Inserts Recalled for Improper Labeling
FDA (Devices) · 2018-08-01
- ModerateOrthofix MINIRAIL external fixation devices recalled for incorrect model labeling
FDA (Devices) · 2026-07-22
- HighOrthofix MINIRAIL external fixation devices recalled for incorrect labeling
FDA (Devices) · 2026-07-22
- HighOrtho Solutions Recalls UltOS 3.5mm Locking Screws Due to Manufacturing Defect
FDA (Devices) · 2015-10-14