Ethicon recalled 516 STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Devices sold worldwide through healthcare providers, including 18 U.S. states and Singapore and Malaysia. The defect is potential barb non-engagement that could compromise tissue control. Clinicians and patients should stop using the device immediately and follow recall instructions from Ethicon.
Potential for barb non-engagement.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ETHICON, LLC or your healthcare provider for instructions. Notification method: Letter
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STRATAFIX Spiral PDS Plus is a knotless tissue control device used in surgical procedures to secure tissue during closures. It is designed for bi-directional use with a spiral configuration.
Barbs on the device may fail to engage tissue as intended, potentially compromising tissue closure and wound integrity.
This recall is not described as part of a broader industry pattern in the provided notice.
The recall creates a safety concern for surgical procedures using this device. Hospitals and surgeons must verify device status and may need to switch to alternatives to ensure proper tissue closure.
Recall notices from Ethicon and FDA enforcement pages. Manufacturer recall communications should list steps for confirmation and return.
Refund or replacement processing commonly falls within 4-8 weeks after verification of eligibility.
Keep copies of the recall notice, device packaging, serial/lot numbers, and all correspondence with the manufacturer or healthcare facility.
Product Code: SXPP2B400-11; GTIN: 10705031464568; Size: 14 x 14 inches (36 x 36 cm); Sold worldwide through healthcare providers; No price listed; Availability and dates of sale not specified.
No injuries or incidents have been reported.
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