FDA-Device2012-09-26Class II
12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS.
Smith & Nephew Inc
Hazard
Modular necks were manufactured out of specification by a vendor; the taper provide is undersized.
Sold states
Worldwide Distribution-USA (nationwide) including the states of CA, FL, GA, IL, IN, MA, NC, NJ, NY, OH, OK, PA, TN, TX, and WA, and the country of Canada.
Affected count
70 units
Manufactured in
1450 E. Brooks Rd, Memphis, TN, United States
Products
12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2427-2012Don't want to check this manually?
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