Arthrosurface Shoulder Prosthetic Components Recalled for Marketing Clearance Issues
Arthrosurface, Inc. is recalling 136 units of HemiCAP shoulder prosthetic 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, which typically corresponds to a Moderate severity score (2) when no specific injuries or illnesses are reported in the source text, and the hazard is primarily regulatory (lack of marketing clearance).
Plain-English summary
Arthrosurface, Inc. is recalling 136 units of the Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component, a HemiCAP Contoured Articular Prosthetic for humeral head resurfacing. The specific items affected are identified by Catalog Number 6105-0028 and Part Number 1105-0028.
The recall was initiated because these fully threaded Taper Post Fixation components were not cleared for marketing in the United States with their current indications. This is a Class II recall, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The products were distributed worldwide, including nationwide in the US 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 Arthrosurface, Inc. for further instructions.
The recalled product
- Product
- Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
- Manufacturer
- Arthrosurface, Inc.
- Affected units
- 136
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: 6105-0028
- Part Number 1105-0028
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 Recalls Uncleared Taper Post Fixation Components
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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 Prosthesis Components Recalled for Lack of US Clearance
FDA (Devices) · 2015-02-18
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