Neuropro Spinal Jaxx recalls Spinal Jaxx Interbody Fusion Device Model 100001-511 due to incorrect implant size etching. The box size is correct but the implant itself has a wrong size marking.
The implant size is incorrectly etched on the implant. The size listed on the box is correct.
Neuropro Spinal Jaxx is recalling a specific spinal fusion device model because the implant size is incorrectly marked. This could lead to improper use if the wrong size is assumed, though the box listing is accurate.
The implant size is incorrectly etched on the device itself, but the box lists the correct size. This could cause confusion during surgical planning or implant placement if the wrong size is assumed, potentially leading to improper fusion.
Patients who received the Spinal Jaxx Interbody Fusion Device Model 100001-511 with incorrect size etching. Skeletally mature patients with degenerative disc disease who have undergone six months of non-operative treatment are most at risk.
Check for the model number 100001-511 and size 9 H x 10 W x 25 L on the device. The product was sold with a lot number 1599 and expired on 10/03/2018.
Verify the model number and size on the implant itself to confirm it matches the recalled specifications.
The device is safe to use if the size is correctly etched. However, this specific model has an incorrect size marking, so it should be checked against the recall information.
Check the device label for the model number 100001-511 and size 9 H x 10 W x 25 L. If it matches, contact Neuropro Spinal Jaxx for further instructions.
The recall indicates a potential for improper use due to incorrect size marking, but no specific risk of serious injury is mentioned in the official notice.
We’ve drafted a message you can send Neuropro Spinal Jaxx to request your refund or repair — edit it as you like.
Subject: Recall Z-1350-2018 — Neuropro Spinal Jaxx Neuropro Spinal Jaxx Hello, I own a Neuropro Spinal Jaxx that is covered by recall Z-1350-2018 from Neuropro Spinal Jaxx. 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.