Smith & Nephew Recalls Rotation Medical Tendon Staples Due to Seal Defects
Smith & Nephew is recalling Rotation Medical Tendon Staples because packaging defects may compromise sterility. The recall affects 6,465 units distributed worldwide.
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 is classified as FDA Class II, and the hazard involves a risk of harm (compromised sterility) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Smith & Nephew Inc. is recalling Rotation Medical Tendon Staples (Product Number 2504-1) due to a potential defect in the packaging process. The issue may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, which could compromise the sterility of the product.
The recall involves 6,305 units in the United States and 160 units outside the United States. The affected products were distributed nationwide in the US and in various countries including Australia, Belgium, Canada, Chile, China, France, Germany, Great Britain, Greece, Hong Kong, India, Italy, Japan, Lithuania, Malaysia, Malta, New Zealand, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovenia, South Africa, Spain, Switzerland, and the United Arab Emirates.
Healthcare providers and facilities should stop using the affected lots and contact Smith & Nephew for instructions on returning the product. The specific batch numbers affected are listed in the official recall notice.
The recalled product
- Product
- ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1
- Manufacturer
- Smith & Nephew Inc.
Distribution
Distributed nationwide across the United States.
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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