Baxter Healthcare recalls Starburst Spine Positioners with adhesive that may not cure properly, risking loss of holding strength during surgery. Affected units have specific model and lot numbers.
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
Baxter Healthcare is recalling Starburst Spine Positioners that use adhesive which might not cure correctly, potentially causing the device to lose strength during surgery. This could lead to complications for patients under anesthesia.
The adhesive applied to screws and bolts may not cure properly, reducing the device's ability to hold securely. This could cause the device to become loose during surgery, potentially affecting patient safety.
Surgical patients and medical staff using the Starburst Spine Positioners during procedures. The risk is highest for those using the specific model with the adhesive issue.
Check for the model name 'Starburst', lot number '22-123', and the unique identifier '00615521002725' on the device. The product is used in surgical procedures to position a patient's head.
Look for the lot number '22-123' and unique identifier '00615521002725' on the device.
The adhesive applied to screws and bolts may not cure correctly, which could reduce the device's holding strength during surgery.
The recall record does not specify a remedy, so no action is required beyond checking if your device matches the described model and lot numbers.
The recall states the adhesive may not cure correctly, but it does not mention a risk of serious injury or death. The danger level is low risk.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0177-2023 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-0177-2023 from Baxter Healthcare. 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.
