Arthrosurface Shoulder Prosthesis Components Recalled for Uncleared Marketing Status
Arthrosurface, Inc. is recalling 138 Taper Post Fixation Components because they were not cleared for marketing in the US with current indications.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a regulatory clearance issue (uncleared marketing status) rather than a direct physical defect causing harm, fitting the 'Moderate' criteria for low-risk or precautionary regulatory actions.
Plain-English summary
Arthrosurface, Inc. is recalling 138 units of the Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component (Catalog Number: 8135-0032, Part Number: 3135-0032). These components are part of the HemiCAP Contoured Articular Prosthetic system used for humeral head resurfacing in orthopedic shoulder procedures.
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. This is a regulatory compliance issue rather than a report of specific product defects or patient injuries.
The affected products were distributed worldwide, including 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 verify their inventory against the specific catalog and part numbers listed.
The recalled product
- Product
- Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: 3135-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
- Manufacturer
- Arthrosurface, Inc.
- Affected units
- 138
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 (2)
- Catalog Number: 8135-0032
- Part Number: 3135-0032
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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