Arthrosurface Recalls Uncleared Taper Post Fixation Components
Arthrosurface, Inc. is recalling 182 units of Athrosurface Taper Post Fixation Components because they were not cleared for marketing in the US with current indications.
What this means for you
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is regulatory (uncleared for marketing) rather than a direct physical defect causing harm, fitting the 'Moderate' criteria for low-risk or voluntary precautionary actions without reported harm.
Plain-English summary
Arthrosurface, Inc. is recalling 182 units of the Athrosurface 40mm 13.75x31mm Taper Post Fixation Component (Catalog Number: 8135-1875, Part Number: 3135-1875). This product is a HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing, used as an orthopedic shoulder prosthesis component.
The recall was initiated because the fully threaded Taper Post Fixation components were not cleared for marketing in the United States with their current indications. The agency classification for this recall is Class II.
The affected products were distributed worldwide, including nationwide in the USA, Europe, Canada, and Australia. However, the source text specifies that only products in the US are affected by this recall. Consumers and healthcare providers should stop using these specific components and contact Arthrosurface, Inc. for further instructions.
The recalled product
- Product
- Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: 3135-1875. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
- Manufacturer
- Arthrosurface, Inc.
- Affected units
- 182
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number: 8135-1875 Part Number: 3135-1875
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Arthrosurface, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
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