XTANT Medical recalls X060-0270 8mm Titanium Insert for misaligned plates that could prevent proper spinal fusion. Affected units have specific UDI and lot numbers. Contact for repair or replacement.
The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.
XTANT Medical is recalling its X060-027: 8mm Titanium Insert for spinal fusion systems. The inserts may not engage properly with crossbar plates, risking improper spinal fusion and potential injury.
The inserts have a misaligned opening that prevents crossbar plates from connecting correctly. This could lead to improper spinal fusion, causing pain, instability, or complications during recovery.
Patients who received the X060-0270 8mm Titanium Insert for spinal fusion surgery are affected. Surgeons and medical staff using the product during procedures are at higher risk.
Check for the UDI (Primary DI Number) M697X06002701 and lot number 058963 on the product. The product was sold with specific model numbers X060-0270 and 8mm Titanium Insert.
Look for the UDI number M697X06002701 and lot number 058963 on the product packaging or label.
The recall states the inserts may not engage properly with crossbar plates, but does not specify if the product is safe when used correctly.
The recall record does not mention a replacement process or contact information.
The recall record does not specify a remedy, so contact XTANT Medical directly for guidance.
We’ve drafted a message you can send XTANT Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0533-2022 — XTANT Medical XTANT Medical Hello, I own a XTANT Medical that is covered by recall Z-0533-2022 from XTANT Medical. 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.
