Smith & Nephew recalls PROFIX Mallet surgical instruments with potential for poly tip to become loose during knee or hip surgery, risking particles entering the surgical field or delays.
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.
Smith & Nephew is recalling reusable surgical mallets that may have a loose poly tip during use. If the tip becomes detached, it could cause particles to enter the surgical field or delay surgery.
The poly tip of the mallet might become loose or detach during use. If this happens, particles from the poly thread could enter the surgical field, or the surgery might be delayed if the tip disengages.
Surgical teams using Smith & Nephew PROFIX Mallets for knee or hip surgery are most at risk. Patients undergoing these procedures with the recalled mallets could face complications.
Check for lot numbers listed in the recall: 17AM17766 through 18LK00128. The mallets are reusable surgical instruments used in knee or hip surgery.
Look for lot numbers on the mallets: 17AM17766 through 18LK00128.
The poly tip may become loose or detach during use, potentially causing particles to enter the surgical field or delaying surgery.
Check the lot number on the mallet. If it matches the listed numbers, stop using it and contact Smith & Nephew for further instructions.
The recall record does not specify a fix or remedy.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0696-2020 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0696-2020 from Smith & Nephew. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
