Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals…
Medical device recall Z-0945-2017. Published in FDA’s Enforcement Report on Jan 11, 2017.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 11, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 11999 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
11999 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
71352401 SMF STEM RSA SIZE 1 71352402 SMF STEM RSA SIZE 2 71352403 SMF STEM RSA SIZE 3 71352404 SMF STEM RSA SIZE 4 71352405 SMF STEM RSA SIZE 5 71352406 SMF STEM RSA SIZE 6 71352407 SMF STEM RSA SIZE 7 71352408 SMF STEM RSA SIZE 8…
Every code shown here, 593 characters
71352401 SMF STEM RSA SIZE 1 71352402 SMF STEM RSA SIZE 2 71352403 SMF STEM RSA SIZE 3 71352404 SMF STEM RSA SIZE 4 71352405 SMF STEM RSA SIZE 5 71352406 SMF STEM RSA SIZE 6 71352407 SMF STEM RSA SIZE 7 71352408 SMF STEM RSA SIZE 8 71352409 SMF STEM RSA SIZE 9 71352501 SMF STEM WITH STIKTITE SZ 1 71352502 SMF STEM WITH STIKTITE SZ 2 71352503 SMF STEM WITH STIKTITE SZ 3 71352504 SMF STEM WITH STIKTITE SZ 4 71352505 SMF STEM WITH STIKTITE SZ 5 71352506 SMF STEM WITH STIKTITE SZ 6 71352507 SMF STEM WITH STIKTITE SZ 7 71352508 SMF STEM WITH STIKTITE SZ 8 71352509 SMF STEM WITH STIKTITE SZ 9
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 15, 2016.
- FDA classified it on Jan 4, 2017.
- FDA’s Enforcement Report published it on Jan 11, 2017.
- FDA terminated it on Aug 19, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Smith & Nephew, Inc., of Memphis, TN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.