Smith & Nephew Recalls SUTUREFIX ULTRA Suture Due to Packaging Error
Smith & Nephew is recalling 868 units of SUTUREFIX ULTRA Suture because a packaging error caused an XL drill to be included instead of the correct S drill.
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, and the hazard involves a packaging error resulting in the wrong size drill being included. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Smith & Nephew, Inc. is recalling 868 units of SUTUREFIX ULTRA Suture, Product number 72203855. The recall involves lot numbers 2038366, 2039311, and 2046505. The product was distributed domestically to 24 states and territories and internationally to 20 countries.
The recall was initiated due to a packaging error where an XL drill was presented for use instead of the required S drill. The source text notes that the XL drill is one inch longer than the S drill.
Consumers and healthcare providers should stop using the affected suture products and contact Smith & Nephew for further instructions.
The recalled product
- Product
- SUTUREFIX ULTRA Suture, Product number 72203855
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 868
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 (2)
- Lot numbers 2038366
- 2039311 and 2046505
Distribution
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