Medical device recalls Moderate risk

Smith & Nephew, Inc. recalls Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical instrument used in hip arthroscopy.

Recall date
January 11, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0793-2016
FDA classification
Class II
Brand / firm
Smith & Nephew, Inc.
Sold / distributed
Worldwide distribution. US Nationwide and countries of AT, AU, BE, CA, CH, CL, CN, CZ, DB, DE, DK, EE, ES, FI, FR, GB, HK, IE, IL, IN, IT, JP, LT, LV, NL, NO, PL, PR, PT, RO, SE, SG, SI, TH, TR, and ZA.

Why it was recalled

Blade exhibiting fracture during hip arthroscopy procedures

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical instrument used in hip arthroscopy.

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