Agency classClass IIOur severity:High FDA (Devices)·Z-0945-2017·Announced 2017-01-11

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.

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 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.
Category: Medical Device — Orthopedic Implant
Hazard: adverse-event
implant-failure
Affected units: 11,999

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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