Smith & Nephew Recalls Modular SMF Hip Prostheses Due to Adverse Events
Smith & Nephew is recalling Modular SMF and Modular REDAPT Hip Systems due to a higher-than-anticipated trend in complaints and adverse events.
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 is classified as FDA Class II and involves a medical device with reported adverse events, but the source text does not specify hospitalizations, deaths, or serious injuries, fitting the 'High' severity criteria for risk-of-harm products where specific severe injury reports are not detailed.
Plain-English summary
Smith & Nephew, Inc. is recalling all lots of Modular SMF and Modular REDAPT Hip Systems. These medical devices are indicated for primary and revision hip surgery in patients with conditions such as trauma, non-inflammatory degenerative joint disease, and inflammatory degenerative joint disease.
The recall was initiated because of a higher than anticipated complaint and adverse event trend associated with the modular neck hip prostheses. The affected units were distributed worldwide, including nationwide in the United States and internationally to countries such as Austria, Australia, Belgium, Canada, and the United Kingdom.
Patients who have had these hip systems implanted should contact their healthcare provider for further instructions. The recall covers 11,999 units of the Modular SMF and Modular REDAPT Hip Systems.
The recalled product
- Product
- Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory degenerative joint
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 11,999
Distribution
Part of a larger recall action
This product is one of 3 recalled by Smith & Nephew, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →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 · adverse event
See all →- SevereOlympus Thunderbeat Surgical Device Recall Due to Adverse Events
FDA (Devices) · 2026-02-25
- SevereOlympus Thunderbeat Surgical Device Recall Over Adverse Events
FDA (Devices) · 2026-02-25
- SevereCoolCurve+ Vacuum Applicator Recalled for Increased Paradoxical Hyperplasia Reports
FDA (Devices) · 2022-07-20
- HighFDA Recalls Vial2BAG Transfer Device Due to Reported Adverse Events
FDA (Devices) · 2019-02-06
- HighWest Pharma Services Recalls Vial2BAG DC 20mm Medical Devices
FDA (Devices) · 2019-02-06