Recall Z-0946-2017— Smith & Nephew, Inc.

Name: FDA recall Z-0946-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-15

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2016-11-15, terminated 2019-08-19. It names 2 FDA 510(k) clearances: K080625, K072417. Product: 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.. Reason: All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-11-15
Terminated: 2019-08-19
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

2 on FDA's record

K080625 — SMITH & NEPHEW MIS HIP STEM WITH STIKTITESmith & Nephew, Inc.·cleared 2008-05-08
K072417 — SMITH & NEPHEW MIS HIP STEMSmith & Nephew, Inc.·cleared 2008-01-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.