Arthrosurface Shoulder Prosthesis Components Recalled for Lack of US Clearance
Arthrosurface, Inc. is recalling 187 units of the HHXL (OVO) 15.6x32mm Taper Post Fixation Component because the product was not cleared for marketing in the US with its 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 regulatory (lack of clearance) rather than a reported physical defect causing harm, fitting the criteria for a moderate severity voluntary or regulatory recall without reported adverse events.
Plain-English summary
Arthrosurface, Inc. is recalling 187 units of the Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component, Catalog Number 8156-0032, Part Number 156-0032. 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 and internationally to 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 the affected components and contact the recalling firm for further instructions.
The recalled product
- Product
- Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
- Manufacturer
- Arthrosurface, Inc.
- Affected units
- 187
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: 8156-0032
- Part Number: 156-0032
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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- ModerateArthrosurface Shoulder Prosthesis Components Recalled for Uncleared Marketing Status
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- HighArthrosurface Shoulder Prosthetic Components Recalled for Marketing Clearance Issues
FDA (Devices) · 2015-02-18
- ModerateArthrosurface Shoulder Prosthetic Components Recalled for Marketing Clearance Issues
FDA (Devices) · 2015-02-18
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