Smith & Nephew Recalls Modular REDAPT Hip Systems Due to Adverse Events
Smith & Nephew is recalling 6,266 units of Modular REDAPT and Modular SMF Hip Systems worldwide due to a higher than anticipated complaint and adverse event trend.
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 the source cites a 'higher than anticipated complaint and adverse event trend' without explicitly reporting deaths or hospitalizations, fitting the criteria for a high-risk product where injury has not yet been explicitly detailed in the provided text.
Plain-English summary
Smith & Nephew, Inc. is recalling 6,266 units of Modular REDAPT and Modular SMF Hip Systems. These medical devices are indicated for individuals undergoing primary and revision surgery for hips damaged by trauma or non-inflammatory degenerative joint disease. The recall covers specific modular neck hip prostheses, including various sizes of MDF REV IMPLANT, REDAPT PROXIMALLY FLUTED STEM, and REDAPT MODULAR SLVD STEM components.
The recall was initiated due to a higher than anticipated complaint and adverse event trend associated with the devices. The source text does not specify the exact nature of the adverse events or the number of reported injuries. The affected units were distributed nationwide in the United States and internationally to numerous countries, including Austria, Australia, Belgium, Canada, China, Germany, India, Mexico, and the United Kingdom.
Consumers and healthcare providers who have these specific hip systems implanted or in inventory should contact Smith & Nephew, Inc. for further instructions. The recall number is Z-0944-2017.
The recalled product
- Product
- Modular REDAPT(TM) Hip Systems 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 de
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 6,266
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.
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