Nextremity recalls specific orthopedic surgical instruments due to oversized driver causing surgery delays. Affected units have SKU NX-3532K-SC and lot number 1681250:17B.
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 two orthopedic surgical instruments that may cause delays during surgery because the driver's proximal end is oversized. This could lead to longer procedures and potential complications for patients.
The proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant. This can cause delays during surgery as the instrument may not fit properly.
Orthopedic surgeons and surgical teams using the Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut instruments. Surgeons using these specific models are most at risk of delayed procedures.
Check for SKU number NX-3532K-SC on the instrument. Affected units were manufactured with lot number 168125017B and have UDI 00817701020059.
Verify the SKU number is NX-3532K-SC and lot number 168125017B.
The 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.
Check the SKU number and lot number to confirm if it's affected. If it matches, contact Nextremity Solutions for further instructions.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Nextremity Solutions to request your refund or repair — edit it as you like.
Subject: Recall Z-0913-2022 — Nextremity Solutions Nextremity Solutions Hello, I own a Nextremity Solutions that is covered by recall Z-0913-2022 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.
