Modular SMF — Class II medical device recall Z-0945-2017
Terminated recall by Smith & Nephew, Inc., reported 2017-01-11, distributed nationwide. All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adve
| Recall number | Z-0945-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2016-11-15 |
| Classified | 2017-01-04 |
| Reported by FDA | 2017-01-11 |
| Terminated | 2019-08-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CN, CY, CZ, DE, DK, ES, FR, GB, GR, HK, IN, IT, MX, NL, PL, PT, RU, TR, ZA |
| Quantity | 11,999 units |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0945-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.