Acumed recalls specific Acutrak 2 screws due to distribution without pre-market clearance. Affected items include 25mm, 30mm, 35mm, 40mm, and 45mm screws with part numbers starting with 30-0021, 30-0023, etc. No action is required as this is a regulatory issue, not a safety hazard.
Distribution without Pre-Market Clearance
Acumed is recalling certain Acutrak 2 screws that were distributed without proper pre-market clearance. This is a regulatory issue, not a safety hazard, so no action is needed. The recall does not pose a risk to consumers.
The hazard is distribution without pre-market clearance, meaning the product was released without proper regulatory approval. This is a compliance issue, not a safety hazard. The product itself is safe to use but does not meet regulatory requirements for distribution.
The recall affects specific Acutrak 2 screws with part numbers starting with 30-0021, 30-0023, 30-0025, etc., sold in the U.S. Most users are surgeons or medical professionals who use these screws in orthopedic procedures.
Check if your Acutrak 2 screws have part numbers starting with 30-0021, 30-0023, 30-0025, 30-0027, or 30-0029 (for 25mm to 45mm screws) or 30-0025-S, 30-0027-S, etc. (for screw sizes).
Review your Acutrak 2 screws' part numbers to confirm if they match the recalled items listed in the recall notice.
This recall is due to distribution without pre-market clearance, which is a regulatory compliance issue, not a safety hazard.
No action is required as this is a regulatory issue, not a safety hazard. The product is safe to use.
Affected part numbers start with 30-0021 (25mm), 30-0023 (30mm), 30-0025 (35mm), 30-0027 (40mm), 30-0029 (45mm), and their 'S' variants.
We’ve drafted a message you can send Acumed to request your refund or repair — edit it as you like.
Subject: Recall Z-0768-2023 — Acumed Acumed Hello, I own a Acumed that is covered by recall Z-0768-2023 from Acumed. 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.
