Reported Feb 18, 2015 · Terminated
Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Number: 1125-0035.…
Arthrosurface, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Arthrosurface, Inc. · 28 Forge Pkwy · Franklin, MA · 02038
Is this the product you have?
- Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component
- Catalog Number6125-0035
- Part Number1125-0035. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component
- Lot codes and dates
- Catalog Number6125-0035
- Part Number1125-0035
- Amount recalled
- 143
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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