Smith & Nephew Recalls Modular Hip Prosthesis Necks Due to Adverse Events
Smith & Nephew is recalling 13,671 modular neck hip prostheses due to a higher than anticipated complaint and adverse event trend.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (implanted medical device) where injury has not yet been explicitly reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
Smith & Nephew, Inc. is recalling 13,671 units of Modular SMF and Modular REDAPT Hip Systems modular necks. The recall covers specific catalog numbers including 71352111, 71352112, 71352116, 71352117, and 71354061. These devices are indicated for primary and revision hip surgery in patients with various joint diseases and are intended for single use without bone cement.
The recall was initiated due to a higher than anticipated complaint and adverse event trend. The source text does not specify the exact nature of the adverse events or the number of reported injuries.
The affected products were distributed worldwide, including nationwide in the United States and internationally to countries such as Austria, Australia, Belgium, Canada, and the United Kingdom. Patients who have had these specific modular necks implanted should contact their healthcare provider for guidance.
The recalled product
- 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 d
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 13,671
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- avascular necrosis
- traumatic arthritis
- slipped capital epiphysis
- fused hip
- fracture of the pelvis
- arthritis secondary to a variety of diseases and anomalies
- and congenital dysplasia
- treatments of nonunion
- endoprosthesis
- femoral osteotomy
- or Girdlestone resection
- fracture-dislocation of the hip
Distribution
Part of a larger recall action
This product is one of 3 recalled by Smith & Nephew, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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