Synthes recalls 3.0mm headless compression screws with incorrect thread length (4mm instead of 6mm) that may not fit properly in medical implants.
The product inside the package does not match the label. The product was labeled as long thread screws that have a 6mm thread length but were actually short thread screws with a 4mm thread length.
Synthes is recalling 3.0mm headless compression screws that were labeled as having a 6mm thread but actually have a 4mm thread. This mismatch could cause improper fixation in medical procedures, potentially leading to complications.
The screws have a shorter thread length (4mm) than labeled (6mm), which could cause them to not engage properly with bone. This might lead to loosening or failure of the implant during healing.
Orthopedic surgeons and medical professionals who use these screws for bone fixation are most at risk. Patients receiving these screws during surgery may experience improper healing.
Check for part number 04.226.118 on the screw package. The screws were sold with lot number L734474. They are used in orthopedic procedures for small bone fractures.
Verify the thread length on the screw package; labeled as 6mm but actual thread length is 4mm.
The screws were labeled as having a 6mm thread length but actually have a 4mm thread length, which could cause improper fixation in medical procedures.
Look for part number 04.226.118 and lot number L734474 on the screw package.
The recall does not specify a remedy, so contact Synthes directly 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-0238-2019 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0238-2019 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.
