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Smith & Nephew, Inc. recalls REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Recalled January 18, 2017 · FDA recall Z-1008-2017 · Smith & Nephew
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. · FDA Class II
Units
4444 units
Sold at
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.
Description
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.
Product
REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Manufacturer(s)
Smith & Nephew, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →