Smith & Nephew Tendon Staples Recalled for Compromised Packaging Sterility
Smith & Nephew is recalling 2,961 units of ROTATION MEDICAL TENDON STAPLES due to improper outer foil pouch sealing that may compromise product sterility. No injuries have been reported.
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: FDA Class II medical device with a sterility compromise due to packaging defect. The source reports no illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Smith & Nephew Inc. is recalling ROTATION MEDICAL TENDON STAPLES (Product Number 72205201), which are intended for fixation of prosthetic material to soft tissues. The recall affects 2,961 units distributed worldwide, including the United States and 30 other countries.
The product's packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch. This compromises the sterility of the device. No illnesses or injuries have been reported related to this issue.
Affected units are identified by UDI-DI code 00885556733486 and the following batch numbers: 51192136, 51192143, 51192144, 51192145, 51192146, 51192148, 51192150, 51192151, 51192152, 51192153, 51192154, 51204480, 51204481, 51204484, 51204485, 51204486, 51204487, 51204488, 51204489, 51204491, 51223193, 51223241, 51223242, 51223243, 51223249, 51224282.
The recalled product
- Product
- ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201
- Manufacturer
- Smith & Nephew Inc.
- Hazard
- sterility-compromise
- contamination-risk
Distribution
Distributed nationwide across the United States.
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