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Terminated

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.

FDA Recall Z-0946-2017 · Posted None

Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeMEH
Date Initiated2016-11-15
Date Terminated2019-08-19
Product Quantity13671 units

Reason for Recall

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

Firm Action

Smith & Nephew sent an Urgent Product Recall Notification letter dated November 15, 2016, to all affected customers. Customers were instructed to inspect their inventory and locate any unused devices and quarantine immediately. Complete the Inventory Return Certification Form and obtain a return authorization (RA) number if there was product to return. For questions regarding this recall call 978-749-1440.

Root Cause

Device Design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K080625SMITH & NEPHEW MIS HIP STEM WITH STIKTITESmith & Nephew, Inc. · 2008-05-08K072417SMITH & NEPHEW MIS HIP STEMSmith & Nephew, Inc. · 2008-01-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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