REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Reported: January 18, 2017 Initiated: November 16, 2016 #Z-1008-2017
Product Description
REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Reason for Recall
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.
Details
- Recalling Firm
- Smith & Nephew, Inc.
- Units Affected
- 4444 units
- Distribution
- 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.
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116. Recalled by Smith & Nephew, Inc.. Units affected: 4444 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 18, 2017. Severity: Moderate. Recall number: Z-1008-2017.
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