SteriSpine PS kits with model numbers KITM640, KITM645, and KITM740 have incorrect screw labeling on patient labels, but the other labels are correct. Affected units include specific lot numbers and UDI codes.
The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct.
SteriSpine PS kits containing two Multi-Axial Fenestrated Screws with model numbers KITM640, KITM645, or KITM740 have been recalled due to incorrect screw labeling on patient labels. This issue does not pose a safety risk to users but requires verification of the labeling to ensure proper use.
The labeling error on patient labels shows the wrong screw type, but the other labels correctly identify the screw. This discrepancy does not cause physical harm or functional issues during use, as the screws are still correctly manufactured and intended for medical procedures.
Orthopedic surgeons and medical professionals using SteriSpine PS kits with the specified model numbers and lot numbers are most likely affected. Patients using these kits are not at risk as the labeling error does not impact safety.
Check for model numbers KITM640, KITM645, or KITM740 on the SteriSpine PS kit. Verify lot numbers and UDI codes as listed in the recall notice to confirm if your kit is affected.
Check the patient label for the correct screw type and compare it with the other labels on the kit.
No, the labeling error does not pose a safety risk. The screws are correctly manufactured, and the issue only affects labeling accuracy, not the product's function.
Model numbers KITM640, KITM645, and KITM740 are affected, with specific lot numbers and UDI codes listed in the recall notice.
No, you do not need to stop using the kit. The labeling error does not impact safety, but verifying the labels is recommended to ensure correct usage.
We’ve drafted a message you can send SteriSpine to request your refund or repair — edit it as you like.
Subject: Recall Z-1572-2022 — SteriSpine SteriSpine Hello, I own a SteriSpine that is covered by recall Z-1572-2022 from SteriSpine. 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.
