Smith & Nephew PROFIX Mallet Recall: Poly Tip May Become Loose During Surgery
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.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/66540-smith-nephew-profix-mallet-recall-poly-tip-may-become-loose.
Source Summary by GovInfoNow · govinfonow.com/recall/66540-smith-nephew-profix-mallet-recall-poly-tip-may-become-loose · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0696-2020
Cite this page
“Smith & Nephew PROFIX Mallet Recall: Poly Tip May Become Loose During Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66540-smith-nephew-profix-mallet-recall-poly-tip-may-become-loose. Based on FDA recall #Z-0696-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0696-2020%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
Check for lot numbers listed in the recall: 17AM17766 through 18LK00128. The mallets are reusable surgical instruments used in knee or hip surgery.
- Brand
Smith & Nephew- Category
Medical device
What to do — step by step
Check Lot Numbers
Look for lot numbers on the mallets: 17AM17766 through 18LK00128.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide distribution and countries of Belgium, Canada, China, Columbia, Costa Rica, Finland, France, Germany, Great Britain, Hong Kong, Italy, Netherlands, Norway, Panama, Poland, Switzerland, United Arab…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 18 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0696-2020 (November 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0696-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.