Medical device manufacturer, Ethicon, has issued a medical device safety alert concerning its STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices [Product Code: SXPP1B430 (Lot: LPH946)].
The manufacturer has identified that the captioned product lot does not meet certain internal testing specifications.
According to manufacturer, no complaints or adverse events related to the issue have been received for the lot codes, and no impact to clinical performance or overall product risk/benefit is expected.
The manufacturer has implemented immediate actions to ensure ongoing manufacturing of STRATAFIX Spiral PDS Plus Knotless Tissue Control Device conforms to all required specifications.
Health care practitioners who have treated patients using the affected lots should follow those patients post-operatively in the usual manner with no additional action required. All unused affected products subject to the recall (removal) are required to be returned.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 9 September 2019