Synthes recalls sterile tube packaging with a possible risk of surgical delay if inner cap opens during use. Affected units include specific lot numbers.
There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field.
Synthes is recalling sterile tube packaging that could cause surgical delays if the inner cap opens when the outer cap is removed. This might happen during surgery preparation, risking delays in critical procedures.
The inner cap might open when the outer cap is removed, or the inner tube might stay inside the outer tube. This could prevent the screw from being used properly, causing delays in surgery.
Surgical teams using this specific sterile tube packaging for procedures. Those preparing for surgery with the recalled product are most at risk.
Check for the part number 04.210.118TS on the packaging. Affected units were sold with lot numbers 6L20592 or 6L37832.
Look for the part number 04.210.118TS and lot numbers 6L20592 or 6L37832 on the sterile tube packaging.
The inner cap might open when the outer cap is removed, or the inner tube might stay inside the outer tube, preventing the screw from being used properly and causing surgical delays.
Check for the part number 04.210.118TS and lot numbers 6L20592 or 6L37832 on the sterile tube packaging.
The official recall notice does not specify a remedy or action for the product.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0882-2020 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0882-2020 from Synthes. 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.
