Ethicon recalls specific STRATAFIX Spiral PGA-PCL sutures due to possible incorrect needle size or length in some lots. Affected products may cause improper surgical use if not checked.
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
Ethicon is recalling certain STRATAFIX Spiral sutures that may have the wrong needle size or length due to a manufacturing mix-up. This could lead to improper surgical use if the sutures are not checked before use.
The recalled sutures may contain the wrong needle type or size, and incorrect suture length due to a component mix-up during manufacturing. This could lead to improper surgical use if the sutures are not checked before use.
Surgical professionals using the recalled STRATAFIX Spiral sutures for procedures. Patients at risk if the incorrect sutures are used during surgery.
Check the product code on the packaging: SXMD1B403-12 for 20cm sutures and SXMD1B100-12 for 30cm sutures. Look for lot numbers AAHM529 or AAHQ049 on the packaging.
Verify the product code and lot number on the packaging to confirm if the item is affected.
Ethicon is recalling STRATAFIX Spiral PGA-PCL sutures with product codes SXMD1B403-12 (20cm) and SXMD1B100-12 (30cm) from lots AAHM529 and AAHQ049.
The recall is due to a possible component mix-up that may result in the wrong needle size or suture length.
Check the product code and lot number on the packaging to confirm if it is affected. If it is, contact Ethicon for further instructions.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-1053-2022 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-1053-2022 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.
