Ethicon recalls 1 STRATAFIX Spiral PDS Plus Violet 12" CT-1 Needle (SXPP1B429) due to failing internal testing specifications. No remedy provided in official notice.
The product do not meet certain internal testing specifications.
Ethicon is recalling a specific type of surgical needle because it did not meet internal testing standards. This means the product may not perform as intended in medical use, though no specific safety risks are described in the recall notice.
The needle failed internal testing specifications, which means it may not function properly during medical procedures. This could lead to complications if the needle does not meet required performance standards in clinical use.
Surgical professionals who use this specific needle model are likely affected. Patients using this product during procedures may be at risk if the needle fails to meet quality standards.
Check for the model number SXPP1B429 on the needle packaging. The product was sold with lot number PAH166 and expired December 31, 2020.
Identify the model number SXPP1B429 and lot number PAH166 on the needle packaging.
The official recall notice does not provide a remedy for this product.
The product was sold with lot number PAH166 and expired December 31, 2020.
The official recall notice does not specify any action steps for affected users.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-1336-2020 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-1336-2020 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.