Smith & Nephew Recalls Reflection Interfit Shell Due to Undersized Radius
Smith & Nephew is recalling 10 units of Reflection Interfit Shells because the inner spherical radius is undersized. The affected devices were distributed in the US and internationally.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a structural defect in a high-risk medical implant (total hip arthroplasty) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Smith & Nephew Inc. is recalling 10 units of Reflection Interfit Shells, Reference 71336052, Batch No. 13EM03053. These sterile medical devices are indicated for cemented or uncemented total hip arthroplasty for various conditions, including rheumatoid arthritis, osteoarthritis, and avascular necrosis.
The recall was initiated because the inner spherical radius of the shell is undersized. This defect could potentially affect the fit or function of the implant during surgical procedures.
The affected units were distributed worldwide, including to New Jersey and Florida in the United States, as well as to Colombia and Costa Rica. Healthcare providers and patients who have received or used these specific devices should contact Smith & Nephew for further instructions on how to proceed.
The recalled product
- Product
- Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post traumatic arthritis, avascular necrosis; femoral and neck…
- Manufacturer
- Smith & Nephew Inc
- Hazard
- Affected units
- 10
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 (1)
- Batch No. 13EM03053
Distribution
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