Synthes recalls sterile tube packaging for 2.4MM TI VA Locking Screw that may cause surgical delays if inner cap opens during use. Affected units include Lot 6L36824.
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 for 2.4MM TI VA Locking Screws that could cause surgical delays if the inner cap opens when the outer cap is removed. This risk affects medical procedures requiring precise screw placement.
The inner cap might open when the outer cap is removed, or the entire inner tube might stay inside the outer tube. This prevents the screw from being properly removed and used during surgery, causing delays in procedures.
Healthcare professionals using sterile surgical screws during procedures are most at risk. Patients undergoing surgery with this specific packaging may experience delays.
Check for the part number 04.210.112TS on sterile tube packaging. Affected units were sold with lot number 6L36824.
Inspect the sterile tube packaging for the part number 04.210.112TS and lot number 6L36824.
The inner cap could open when the outer cap is removed, or the entire inner tube might remain in the outer tube, preventing proper screw use during surgery.
This could cause surgical delays if the screw cannot be properly removed and used during the procedure.
Check the packaging for part number 04.210.112TS and lot number 6L36824. If affected, 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-0880-2020 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0880-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
