Zimmer Biomet recalls specific compress devices and instruments due to a correction in surgical technique instructions for anti-rotation pins. Affected items include various spindle and sleeve models.
Correction to update the surgical technique for the Compress System. To make users aware of the changes that were made only to the selection criteria section on page 42 regarding which array to use in the placement of the anti-rotation pins.
Zimmer Biomet is recalling specific compress devices and instruments because surgical technique instructions were updated. This correction affects how anti-rotation pins are placed during procedures, but it does not pose a safety risk to users.
The recall involves updating the surgical technique instructions for placing anti-rotation pins. The correction focuses on which array to use in the placement process, but it does not involve a physical hazard or risk of injury.
Surgical professionals using Zimmer Compress Devices and Instruments with the listed item numbers are affected. The risk is minimal as this is a correction to instructions, not a safety hazard.
Check if your device has item numbers like 178350, 178353, 178356, or other listed models from the recall notice. These items are used in surgical procedures and include specific spindle and sleeve components.
Check the surgical technique instructions for the placement of anti-rotation pins to ensure you are using the updated selection criteria.
Zimmer Biomet is recalling these devices to update the surgical technique instructions for anti-rotation pins, specifically the selection criteria for which array to use during placement.
No, you do not need to stop using these devices. This is a correction to the instructions, not a safety hazard.
Affected item numbers include 178350, 178353, 178356, 178537, 178541, 178545, 178544, 178738, 178542, 32-481123, 178757, 178758, 178759, 178787, 178788, and 178789.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0642-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0642-2019 from Zimmer 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.
