Ethicon, Inc. is recalling 395 units of the STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device because the product may be degraded and unusable upon removal from its packaging. The devices were exposed to improper environmental conditions during transit and storage, which compromised the sterility of the medical suture. These surgical devices are primarily used in soft tissue approximation where absorbable sutures are appropriate. Consumers and healthcare facilities should immediately identify and sequester the affected lot SHBAEC with an expiration date of June 30, 2024.
The exposure to improper environmental conditions during shipping and storage has compromised the sterility of the device. Using a non-sterile or degraded suture during a surgical procedure can lead to post-operative infections or failure of the tissue approximation, potentially requiring additional medical intervention.
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If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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