Ethicon recalls STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle sutures due to failing internal strength tests. Affected products have product code SXPP1B401 and lot number MMH401. Consumers should contact Ethicon for details.
The product does not meet certain internal strength testing specifications.
Ethicon is recalling STRATAFIX Spiral PDS Plus Violet 27 (70cm) CT: Needle sutures because they don't meet internal strength testing standards. This could lead to the suture failing during use, potentially causing injury or complications in medical procedures.
The suture does not meet internal strength testing specifications, which means it may not hold up under stress during medical procedures. This could potentially lead to the suture breaking or failing when used, causing complications or injury.
Medical professionals and patients who use this specific suture product are affected. The risk is low as the issue relates to strength testing, not immediate failure in normal use.
Check for product code SXPP1B401 and lot number MMH401 on the suture packaging. This specific suture is sold under the brand Ethicon.
Reach out to Ethicon directly for specific instructions on handling the recalled product.
The recall states the product does not meet internal strength testing specifications, but it does not indicate immediate danger in normal use. The risk is considered low.
Look for product code SXPP1B401 and lot number MMH401 on the suture packaging.
Contact Ethicon directly for specific instructions on handling the recalled product.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-0048-2020 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-0048-2020 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.
