FDA-Device2019-03-27Class II

smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM, REF 713552511

Smith & Nephew, Inc.
Hazard

Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"

Sold states
US: CA, TN, NC, AR, IN, FL, MO, and, Canada, China, France, Germany, Great Britain, India, Italy, Japan, Mexico, Poland, South Korea, Spain
Affected count
9 units
Manufactured in
1450 E Brooks Rd, N/A, Memphis, TN, United States
Products
smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM, REF 713552511

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1029-2019

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