Reported Dec 25, 2019 · Terminated
smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical…
Smith & Nephew, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smith & Nephew, Inc. · 1450 E Brooks Rd · Memphis, TN · 38116-1804
Is this the product you have?
- smith&nephew PROFIX Mallet, 750 GRAMS
- REF 71512452 - Product UsageThe PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery
- Lot codes and dates
- Lot Numbers
180 of 180 codes
17AM1776617AM1776717CM0179817CM0179917CM0180017CM0180117CM0180217CM0180317CM0180417CM0180517CM0180617CM0180717CM0263617CM0263717CM0263817CM0263917CM0264017CM0264117CM02641A17CM0264217CM0264317CM0264417CM0264517CM0264617CM0264717CM0264817CM0504717CM0504817CM0504917CM0505017CM05050A17CM0505117CM0505217CM0505317CM0505417CM0505517CM0505617CM0505717CM0505817CM0505917CM0798517CM0798617CM0798717CM0798817CM1016417CM1016617CM1016817CM1548817CM1549017CM1549217CM1549317CM1549417CM1549617CM1549917CM1946317CM1946417CM1946617CM1946817CM1946917CM19470
- Lot Numbers
- Amount recalled
- 1371 devices
Where it was sold
- Nationwide
Why it was recalled
There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet may become loose and/or come off during use. If the potential failure mode occurs, particles generated in the poly thread potentially could enter the surgical field or a delay in surgery could occur if the tip disengages during the use of the mallet.
This product could cause temporary or reversible health problems — stop using it.
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