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.
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: 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.
- Affected units
- 2,961
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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