Smith & Nephew Recalls R3 XLPE Acetabular Liners Due to Mislabeling
Smith & Nephew is recalling specific batches of R3 XLPE acetabular liners because some 60 mm and 62 mm units may be mislabeled with incorrect size markings.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a labeling/packaging error without reporting any injuries, illnesses, or deaths. Per the rubric, minor labeling errors or voluntary precautionary recalls without reported harm fall under Moderate severity.
Plain-English summary
Smith & Nephew Inc is recalling 53 units of R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, STERILE H2O2, REF 71335760. The recall involves Batch No. 12FM00602. The product is an orthopaedic device used in hip replacement surgery.
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 mislabeling could result in the implantation of an incorrectly sized component during surgery.
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 facilities should check their inventory for this specific batch number and stop using the affected devices.
The recalled product
- Product
- R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760. Orthopaedic.
- Manufacturer
- Smith & Nephew Inc
- Hazard
- 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. 12FM00602
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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