Ethicon recalls 1 STRATAFIX Spiral PDS Plus Violet 18" OS-6 needles (lot PAH360) due to not meeting internal testing specs. No remedy stated in official notice.
The product do not meet certain internal testing specifications.
Ethicon is recalling a specific type of surgical needle because it failed internal testing. This means the product may not work as intended during medical procedures, potentially causing complications.
The needle failed internal testing specifications, which could mean it doesn't function properly during surgery. This might lead to complications like improper tissue sealing or other surgical issues.
Surgical staff and hospitals that purchased the recalled needle model (SXPP1B201) from the manufacturer. Patients using this needle during procedures may be at risk if the product fails.
Check for the model number SXPP1B201 on the needle packaging. The lot number PAH360 and expiration date 12/31/2020 are also associated with this recall.
Look for the model number SXPP1B201 and lot number PAH360 on the needle packaging.
The official recall notice does not state any remedy or replacement options.
Check for the model number SXPP1B201 and lot number PAH360 on the packaging.
The official 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-1334-2020 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-1334-2020 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.
