Smith & Nephew Recalls Reflection Acetabular Liners Due to Tolerance Issues
Smith & Nephew is recalling 38 units of Reflection acetabular liners because they may be out of tolerance and fail to fully seat into the shell.
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 medical device defect (liner not seating) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Smith & Nephew Inc is recalling 38 units of Reflection Microstable Acetabular Liners. The specific product affected is the 20o Overhang, 28 MM ID, 54-56 OD model, sterile EO, reference 71742854, batch number 12BM04836.
The recall was initiated because one batch of these liners may be out of tolerance, which could cause the liner not to fully seat into the shell. The affected units were distributed in China and Spain.
Healthcare providers and patients who have received these specific implants should contact Smith & Nephew Inc for further instructions regarding the recall and potential replacement.
The recalled product
- Product
- REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, Smith & Nephew, Inc. Memphis, TN 38116 USA. Orthopaedic.
- Manufacturer
- Smith & Nephew Inc
- Affected units
- 38
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. 12BM04836
Distribution
Distribution scope not specified by the agency.
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