Synthes recalls torque limiting handles with part number 03.231.013 due to potential rust from high-carbon ball bearings, which may affect fracture fixation systems.
The adapter may demonstrate a degradation of function as the final products were assembled with ball bearings of high carbon content that is likely to rust prematurely.
Synthes is recalling a specific torque limiting handle used in fracture fixation systems because the ball bearings could rust prematurely. This might cause the handle to stop working properly during medical procedures.
The handle uses ball bearings made with high-carbon content that may rust over time. Rust could cause the handle to lose its torque-limiting function, potentially affecting the safety of fracture fixation procedures.
Medical professionals who use this handle for fracture fixation are most at risk, as the handle is part of surgical equipment.
Check for part number 03.231.013 on the handle. These handles were sold with specific model numbers like H344006-02 to H344006-49 and H369323-03 to H369323-04.
Look for part number 03.231.013 on the handle to confirm if it is recalled.
The handle's ball bearings may rust prematurely due to high-carbon content, which could cause the handle to stop working properly during fracture fixation procedures.
Check the part number on the handle. If it is 03.231.013, stop using it and contact Synthes for further instructions.
The recall indicates a potential risk of premature rust, but the handle is still safe to use until the issue is addressed. Always check the part number.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-1916-2018 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-1916-2018 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.
