FDA-Device2017-01-18Class II
REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Smith & Nephew, Inc.
Hazard
The firm received complaints of cracks in the weld on the head of the mallet. In the reported cases, some of the lead beads and particles escaped from the mallet into the surgical wound.
Sold states
Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the countries of : Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, China, Colombia, Costa Rica, Dubai, Denmark, Germany, Finland, France, Great Britain, Greece, Hong Kong, Ireland, Israel, India, Italy, Japan, Mexico, Malaysia, Netherlands, Norway, Poland, Portugal, Puerto Rico, South Africa, Sweden, Singapore, Switzerland, Thailand, Turkey and Venezuela.
Affected count
4444 units
Manufactured in
1450 E Brooks Rd, Memphis, TN, United States
Products
REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1008-2017Don't want to check this manually?
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