Recall of specific NuVasive Precice Bone Transport components due to risk of bone plug detaching during removal. Affected items include certain femur and tibia components with specific lot numbers.
During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system.
NuVasive is recalling specific bone transport components used in orthopedic surgery. During removal, standard tools can cause the bone plug to detach from the device, potentially leading to complications.
During removal of the device, standard surgical tools can generate enough force to cause the bone plug to separate from the bone transport system. This could lead to the plug becoming dislodged and potentially causing complications.
Orthopedic surgeons and patients who have received the recalled components during surgery. Those with the specific lot/serial numbers listed are most at risk.
Check the item number and lot/serial number on the component. Affected items include specific models like PA1160-10D400-7 with lot numbers starting with 9011815AAA, 9021510AAA, etc.
Identify the item number and lot/serial number on the recalled component to confirm if it is affected.
Specific bone transport components including femur and tibia parts with item numbers like PA1160-10D400-7 and associated lot/serial numbers.
Check the item number and lot/serial number on the component. Affected items have specific lot numbers starting with 9011815AAA, 9021510AAA, etc.
Check the component details to confirm if it is affected. If it is, contact NuVasive for further instructions.
We’ve drafted a message you can send NuVasive to request your refund or repair — edit it as you like.
Subject: Recall Z-0069-2021 — NuVasive NuVasive Hello, I own a NuVasive that is covered by recall Z-0069-2021 from NuVasive. 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.