Smith & Nephew Recalls R3 XLPE Acetabular Liners Due to Packaging Error
Smith & Nephew is recalling 53 units of R3 XLPE acetabular liners because some 60 mm and 62 mm liners may be laser etched and packaged with incorrect size labels.
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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Smith & Nephew Inc is recalling 53 units of R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. The recall involves Batch No. 12FM00603. The product is an orthopaedic medical device.
The recall was initiated because one batch of 60 mm 20o R3 XLPE liners may be laser etched and packaged as a 62 mm 20o liner, and one batch of 62 mm 20o R3 XLPE liners may be laser etched and packaged as a 60 mm 20o liner. This labeling discrepancy could result in the implantation of an incorrectly sized liner.
The affected units were distributed worldwide, including in the United States (PA, WA, TX, FL, IA, MI, WI, TN, KY, IN, NY, MO, and OR) and in India, Canada, Chile, Venezuela, Dubai, South Africa, Australia, Poland, Romania, Belgium, Germany, and the United Kingdom. Healthcare providers and patients should verify the size of the liner against the packaging and contact Smith & Nephew for further instructions.
The recalled product
- Product
- R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. Orthopaedic.
- Manufacturer
- Smith & Nephew Inc
- Affected units
- 53
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. 12FM00603
Distribution
Part of a larger recall action
This product is one of 2 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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