Ethicon recalls STRATAFIX Spiral Monocryl Plus devices that may have lost sterility during shipping, risking infection. Affected units were shipped with foil pouches that degraded due to environmental exposure.
Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
Ethicon is recalling STRATAFIX Spiral Monocryl Plus devices that may have lost sterility during shipping. Using these devices could lead to infections since they are no longer sterile.
The devices can become contaminated during shipping and storage because the foil pouches degrade when exposed to environmental conditions. This compromises the sterility of the product, increasing the risk of infection during surgery.
Surgical professionals and patients who received STRATAFIX Spiral Monocryl Plus devices for soft tissue approximation procedures. Those who used the product after the expiration date or without proper sterility checks are at higher risk.
Check for product code SXMP2B412 or UDI/GTIN 30705031464289 (box) and 10705031464285 (pouch). The lot number SHBAEC with an expiration date of June 30, 2024, indicates the affected batch.
Look for product code SXMP2B412 or UDI/GTIN 30705031464289 (box) and 10705031464285 (pouch) on the packaging.
Ethicon recalls STRATAFIX Spiral Monocryl Plus devices that may have lost sterility during shipping and storage due to degraded foil pouches.
Check the product code and expiration date. If it matches the affected batch, contact Ethicon for guidance.
Yes, using devices that have lost sterility could lead to infections during surgery.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-1533-2024 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-1533-2024 from Ethicon. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
