483
Arthrosurface, Inc.Arthrosurface, Inc. – FDA 483, Apr 1, 2026
Record Details
An FDA inspection of Arthrosurface, Inc. in West Bridgewater, MA, revealed significant deficiencies in the documentation and validation of sterilization processes for their orthopedic implants. The firm failed to provide evidence of required reviews for dose audits and lacked documented rationale for changes in bioburden limit formulas. Additionally, the recommended sterilization time for reusable instrument sets had not been validated.
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ID · 7c2e9363-6531-4034-9789-99a725f8aef1
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