Synthes recalls sterile tube packaging with a risk of inner cap opening during use, causing surgical delays. 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 may open unexpectedly during surgery, potentially delaying procedures. This could affect medical procedures requiring precise timing.
The inner cap might open when the outer cap is removed, or the inner tube might stay inside the outer tube. This prevents the screw from being properly removed and used, leading to surgical delays.
Healthcare professionals using the sterile tube packaging for surgical procedures are most at risk. Patients undergoing surgery with this product may experience delays.
Check for the part number 04.210.116TS on the packaging. Affected units were sold with lot numbers 6L20591 or 6L37063.
Look for the part number 04.210.116TS and lot numbers 6L20591 or 6L37063 on the sterile tube packaging.
The inner cap could open when the outer cap is removed, or the inner tube might remain inside the outer tube, preventing the screw from being used and causing surgical delays.
Check for the part number 04.210.116TS and lot numbers 6L20591 or 6L37063 on the sterile tube packaging.
The recall record does not specify a remedy, so contact Synthes for guidance.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0881-2020 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0881-2020 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.
