Nextremity Solutions recalls Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit (SKU NX-4532K) due to oversized driver causing surgery delays. Affected units have specific lot numbers.
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
Nextremity Solutions is recalling a specific orthopedic surgical kit for hammertoe correction because the driver's proximal end is oversized, which can cause delays during surgery. This recall affects surgeons and hospitals using the kit with the listed lot numbers.
The proximal end of the driver in the kit is oversized in varying degrees. This makes it difficult to fully connect and remove from the proximal Nextra implant during surgery, potentially causing delays in the procedure. However, the hazard does not involve patient injury or death.
Surgeons and hospitals using the Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit (SKU NX-4532K) with lot numbers 168117318B or 168125017C are affected. The risk is low as this is a surgical instrument issue that only impacts procedure timing, not patient safety directly.
Check for the product name 'Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit' with SKU NX-4532K. Affected units have lot numbers 168117318B or 1681250017C.
Look for lot numbers 168117318B or 168125017C on the kit packaging or label.
The proximal end of the driver is oversized in varying degrees, making it difficult to fully connect and remove from the proximal Nextra implant, causing delays in surgery.
Check the lot number on the kit. If it's 168117318B or 168125017C, contact Nextremity Solutions for instructions.
The recall is for surgery delays, not patient injury. The hazard does not involve direct harm to patients.
We’ve drafted a message you can send Nextremity Solutions to request your refund or repair — edit it as you like.
Subject: Recall Z-0910-2022 — Nextremity Solutions Nextremity Solutions Hello, I own a Nextremity Solutions that is covered by recall Z-0910-2022 from Nextremity Solutions. 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.