Z-0946-2017Class II

Modular Necks: The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals...

Name: Z-0946-2017 Modular Necks: The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals...
Creator: Smith & Nephew, Inc.
Published: 2016-11-15
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2016-11-15 / Terminated / root cause: design

FDA source

Smith & Nephew, Inc. began a recall of Modular Necks: The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other... on 2016-11-15. FDA classified it as Class II and gives the reason as "All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0946-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-15
Posted: 2017-01-04
Terminated: 2019-08-19
Recalling firm: Smith & Nephew, Inc.
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.
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Reason for recall: All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 13671 units
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0946-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0944-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-11	2017-01-04
Z-0945-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-11	2017-01-04
Z-0946-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-11	2017-01-04

Product code MEH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)