Alphatec recalls specific disc preparation instruments due to manufacturing issues that may require regulatory filing. Check product details to see if your item is affected.
Due to manufacturing instruments which included additional features and adequate consideration was not given to the need for a new Regulatory filing.
Alphatec is recalling certain disc preparation instruments that were manufactured without proper regulatory filing. This could lead to potential compliance issues, but the recall does not indicate immediate safety hazards.
The instruments were manufactured without adequate regulatory filing, which may not pose a direct safety risk but could lead to compliance issues with medical regulations. This does not indicate a risk of injury or malfunction during normal use.
Medical professionals using these instruments for spinal procedures are most likely affected. The recall targets specific models sold for clinical use.
Check for product names like 'Longer IdentiTi PO Trial Tip' or 'Longer Rotating Disc Shaver' with specific model numbers listed in the recall notice. The recall includes items with TC11050, TC11051, or TC11052 part numbers.
Review the product names and model numbers listed in the recall notice to determine if your instrument is affected.
The recall states a manufacturing issue related to regulatory filing, but does not indicate a risk of injury or malfunction during normal use.
Look for product names like 'Longer IdentiTi PO Trial Tip' or 'Longer Rotating Disc Shaver' with specific model numbers listed in the recall notice.
The recall does not specify a remedy, so you may continue using the instruments if they are functioning properly.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-0196-2023 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-0196-2023 from Alphatec. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
