Smith & Nephew Recalls PROFIX Mallets Due to Tip Detachment Risk
Smith & Nephew is recalling 1,371 PROFIX Mallets because the poly tip may detach during surgery, potentially releasing particles into the surgical field.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where the tip could detach and release particles into the surgical field, but no injuries or illnesses have been reported.
Plain-English summary
Smith & Nephew, Inc. is recalling 1,371 units of the PROFIX Mallet, a reusable surgical instrument used to tap instruments or implants during knee or hip surgery. The recall involves specific lot numbers distributed worldwide, including in the United States, Belgium, Canada, China, and other countries.
The recall is due to a potential failure mode where the poly tip of the mallet may become loose or come off during use. If this occurs, particles from the poly thread could enter the surgical field, or a delay in surgery could happen if the tip disengages.
Healthcare facilities and users should stop using the affected mallets and contact Smith & Nephew for instructions on how to return or dispose of the devices.
The recalled product
- Product
- smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery.
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 1,371
Distribution
Distributed nationwide across the United States.
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