Nextremity Solutions recalls Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit (SKU NX-3532K) due to oversized driver causing surgery delays. Affected units have Lot Number 168125017A or UDI 00817701020042.
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. This can cause delays during surgery by making it difficult to connect and remove the implant properly.
The driver's proximal end is oversized in varying degrees, which makes it difficult to fully connect with and remove the proximal Nextra implant. This can cause delays in surgery but does not typically cause injury or harm to patients.
Orthopedic surgeons and surgical teams using the Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit (SKU NX-3532K) are affected. The risk is low as this is a surgical instrument issue that only impacts procedures, not end-users.
Check for the product name 'Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit' with SKU NX-3532K. Affected units have Lot Number 168125017A or Unique Device Identifier (UDI) 00817701020042.
Verify the product name, SKU, lot number, and UDI to confirm if your kit is affected.
The recall addresses a surgical instrument issue that may cause delays in procedures but does not typically cause injury or harm to patients.
Check for the product name 'Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit' with SKU NX-3532K. Affected units have Lot Number 168125017A or UDI 00817701020042.
The official recall does not specify a remedy, so contact Nextremity Solutions directly for guidance.
We’ve drafted a message you can send Nextremity Solutions to request your refund or repair — edit it as you like.
Subject: Recall Z-0912-2022 — Nextremity Solutions Nextremity Solutions Hello, I own a Nextremity Solutions that is covered by recall Z-0912-2022 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.