Biomet recalls shoulder prosthesis inserters with specific serial numbers due to potential screw drill seizure causing extended surgery. Affected units include items with UDI codes (01)00880304829503 and lots 814100, 570640, 728890, 977300.
The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement device.
Biomet is recalling certain shoulder prosthesis inserters that may cause the central screw drill to seize during surgery, potentially requiring extended procedures to find a replacement device. This risk affects patients undergoing shoulder replacements with the specific model and serial numbers listed in the recall.
The central screw drill can seize inside the device during surgery, which may require additional time and steps to locate a replacement device. This could lead to longer surgical procedures and increased risks for the patient.
Patients who have received the recalled Comprehensive VRS Inserter for shoulder replacement surgery are most at risk. Healthcare providers using the device during procedures may also be affected.
Check for the product name 'Comprehensive VRS Inserter' and the specific UDI codes (01)00880304829503 with lots 814100, 570640, 728890, or 977300. The device is used in shoulder replacement surgeries.
Identify the UDI code and lot number on the device to confirm if it is affected.
The device may cause the central screw drill to seize during surgery, potentially requiring extended procedures to find a replacement device.
Check the UDI code and lot number to confirm if it is affected; contact Biomet for further instructions.
The recall states the risk is extended surgery, not direct injury, so the danger level is use caution.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2300-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2300-2020 from Biomet. 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.
