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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
Related recalls
Same manufacturer · Smith & Nephew, Inc.
See all →- HighTRIGEN proximal humeral nails are missing their distal holes
FDA (Devices) · 2026-06-24
- ModerateBone fixation screws recalled over a labeling error on one lot
FDA (Devices) · 2025-12-24
- ModerateSmith & Nephew Lag/Compression Screw Kit Undersized Socket Defect
FDA (Devices) · 2025-05-28
- HighBIORAPTOR Suture Anchors Recalled for Sterile Barrier Packaging Breach
FDA (Devices) · 2024-12-11
- HighSmith & Nephew Bipolar Hip Implant Component Recalled for Oversized Retainer Ring
FDA (Devices) · 2024-11-13
Same hazard · foreign object
See all →- ModerateMezzetta Golden Greek Peperoncini Recalled for Potential Mouse Contamination
FDA (Food) · 2026-10-14
- SevereUnited and Good & Gather Light Brown Sugar Recalled for Wheat Contamination
FDA (Food) · 2026-09-30
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
- ModerateBionpharma Recalls Doxylamine Succinate Tablets Due to Foreign Material Presence
FDA (Drugs) · 2026-09-09
- SevereTeva Recalls Trazodone Hydrochloride Tablets Due to Foreign Material
FDA (Drugs) · 2026-09-09
Similar recalls
- HighSmith & Nephew Recalls Modular Hip Prosthesis Necks Due to Adverse Events
FDA (Devices) · 2017-01-11
- SevereSmith & Nephew BEAVER Blade 4.0mm Recalled for Fracture Risk
FDA (Devices) · 2016-02-17
- HighSmith & Nephew Recalls Modular SMF Hip Prostheses Due to Adverse Events
FDA (Devices) · 2017-01-11
- HighSignal Medical Soft Face Mallet Recalled for Tip Detachment Risk
FDA (Devices) · 2017-04-26
- HighSmith & Nephew Recalls Modular REDAPT Hip Systems Due to Adverse Events
FDA (Devices) · 2017-01-11
- HighSmith & Nephew Recalls Journey II Uni Resection Prep Trial Instruments
FDA (Devices) · 2020-06-03