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Recall Observatory FDA recall evidence

Device product

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

Z-1029-2019

February 19, 2019

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 82193
Status
Terminated
Classification
Class II
Quantity
9 units
Official record key
device-enforcement:Z-1029-2019

Official wording

Reason: 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"

Code information: 11CM01091T, 11EM12764T, 11EM12764U, 13MM16036B, 14GM13037D, 15MM09360A, 15MM10833A, 18CM24036 & 18EM15257

Distribution pattern: US: CA, TN, NC, AR, IN, FL, MO, and, Canada, China, France, Germany, Great Britain, India, Italy, Japan, Mexico, Poland, South Korea, Spain

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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"