Agency classClass IIOur severity:High FDA (Devices)·Z-0944-2017·Announced 2017-01-11

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.

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 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…
Manufacturer: Smith & Nephew, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: adverse-event
device-failure
Affected units: 6,266

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 →

Same manufacturer · Smith & Nephew, Inc.

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