Smith & Nephew Recalls Polarstem Collar Reamer Guides Due to Design Issue
Smith & Nephew is recalling 528 units of the Polarstem Collar Reamer Guide due to a product design issue. The devices were distributed worldwide and in the US.
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 2/5 (Moderate).
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, which typically indicates a temporary or medically reversible adverse health consequence. The source text cites a product design issue but does not report specific injuries, illnesses, or fatalities, aligning with a moderate severity rating for a medical device with a theoretical or unreported risk.
Plain-English summary
Smith & Nephew Orthopaedics AG is recalling 528 units of the POLARSTEM COLLAR Reamer Guide, Catalog Number 75102205. The recall is being conducted due to a product design issue. The affected serial numbers are A56281, A57539, A58660, A600630, A61590, A62616, and A62689.
The recalled devices were distributed worldwide, including nationwide in the United States and in Australia, Belgium, Canada, Switzerland, Spain, France, Great Britain, Japan, the Netherlands, Norway, Poland, Singapore, and South Africa. The product is a surgical instrument used to position a calcar reamer on a rasp during femoral neck machining.
Healthcare providers and consumers should stop using the affected reamer guides and contact Smith & Nephew Orthopaedics AG for further instructions on the recall.
The recalled product
- Product
- POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide (75102205) is positioned on the rasp. The calcar reamer (75102207 or 75102208)…
- Manufacturer
- Smith & Nephew Orthopaedics AG
- Hazard
- Affected units
- 528
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 (6)
- Serial Numbers: A56281
- A57539
- A58660
- A600630
- A61590
- A62616 & A62689
Distribution
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