Smith & Nephew, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0946-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Modular Necks: 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 disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity. The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are intended for single use only and are to be implanted without bone cement.

Product Classification:

Class II

Date Initiated: November 15, 2016

Date Posted: January 11, 2017

Recall Number: Z-0946-2017

Event ID: 75873

Reason for Recall:

All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend.

Status: Terminated

Product Quantity: 13671 units

Code Information:

71352111 STANDARD OFFSET NEUTRAL MODULAR NECK 71352112 HIGH OFFSET NEUTRAL MODULAR NECK 71352116 LEFT ANTEVERTED MODULAR NECK 71352117 RIGHT ANTEVERTED MODULAR NECK 71354061 MOD NECK HO +10 NECK HEIGHT 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 disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity. The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are intended for single use only and are to be implanted without bone cement.

Distribution Pattern:

Worldwide Distribution - US (nationwide) and Internationally to Austria, Australia, Belgium, Canada, Switzerland, China, Cyprus, Czech Republic, Dubai, Germany, Denmark, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Mexico, Netherlands, Poland, Puerto Rico, Portugal, Russia, Turkey, and South Africa.

Voluntary or Mandated:

Voluntary: Firm initiated