Ethicon recalls 1 STRATAFIX Spiral PDS Plus Violet 36" CTX Needle (SXPP1B402) with lot numbers PAH073 and PAH054 due to not meeting internal testing specifications. No remedy is specified in the recall 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, but the recall does not include a fix or return process.
The needle failed internal testing specifications, which could mean it doesn't function properly during surgery. This might lead to complications if the needle doesn't meet the required performance standards.
Surgical professionals who purchased the recalled needle model are likely affected. Patients using this needle during procedures may be at risk if the product fails to meet testing standards.
Check for the model number SXPP1B402 on the needle packaging. The lot numbers PAH073 and PAH054, and expiration date 12/31/2020 are also listed in the recall notice.
Look for the model number SXPP1B402, lot numbers PAH073 or PAH054, and expiration date 12/31/2020 on the needle packaging.
The recall notice does not specify any remedy or action steps for the product.
The expiration date for the recalled needle is 12/31/2020.
Lot numbers PAH073 and PAH054 are affected by this recall.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-1335-2020 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-1335-2020 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.
