Premia Spine recalls TOPS Inserter model 82889 due to potential missing pins at the tip, which could cause implantation issues. Affected units include specific lot numbers and model.
Potential for missing pins at tip of inserter.
Premia Spine is recalling a specific TOPS Inserter model (82889) because it may have missing pins at the tip during surgery. This could lead to improper implantation of the TOPS System. Affected users should check their lot numbers and contact the company for instructions.
The inserter may have missing pins at the tip, which could cause the TOPS System to not implant correctly during spinal surgery. This might lead to complications in the surgical procedure.
Surgical teams using the TOPS Inserter model 82889 for spinal implant procedures. Patients who have undergone spinal surgery with this specific model are at risk of improper implantation.
Check for model number 82889 on the inserter. Look for lot numbers: RS20220546-1, RS20222162-1, RS20171777-1, RS20171884-1, RS0431-13B-1, 20152764-1, or RS0431-02-1.
Look for model number 82889 on the TOPS Inserter.
Reach out to Premia Spine for specific instructions on how to handle the recalled item.
The model number is 82889.
Affected lot numbers include RS20220546-1, RS20222162-1, RS20171777-1, RS20171884-1, RS0431-13B-1, 20152764-1, and RS0431-02-1.
Check for model number 82889 and any of the listed lot numbers on the device.
We’ve drafted a message you can send Premia Spine to request your refund or repair — edit it as you like.
Subject: Recall Z-2516-2025 — Premia Spine Premia Spine Hello, I own a Premia Spine that is covered by recall Z-2516-2025 from Premia Spine. 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.
