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Terminated

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

FDA Recall Z-0793-2016 · Posted None

Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeNBH
Date Initiated2016-01-11
Date Terminated2017-09-18
Product Quantity69043 units

Reason for Recall

Blade exhibiting fracture during hip arthroscopy procedures

Firm Action

Smith & Nephew issued letters via Federal Express on January 11, 2016. requested to inspect inventory and locate any unused devices and quarantine them immediately. Complete Inventory Return Certification Form on the following page, indicating the quantities that need to be returned. Contact Smith & Nephews Field Action Department via email at [email protected] or fax +1-901-566-7975 to obtain a return authorization (RA) number.

Root Cause

Device Design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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