Lower risk Medical device recall · FDA · Published May 4, 2018

Synthes Torque Handle Recall: Rust Risk in Fracture Fixation Devices

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1916-2018Medical device Synthes ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmSynthes (USA) Products LLC1301 Goshen Pkwy · West Chester, PA 19380-5986

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/71203-synthes-torque-handle-recall-rust-risk-in-fracture-fixation-devices.

Source Summary by GovInfoNow · govinfonow.com/recall/71203-synthes-torque-handle-recall-rust-risk-in-fracture-fixation-devices · Updated August 21, 2026 · FDA enforcement record: FDA #Z-1916-2018

Cite this page

“Synthes Torque Handle Recall: Rust Risk in Fracture Fixation Devices.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71203-synthes-torque-handle-recall-rust-risk-in-fracture-fixation-devices. Based on FDA recall #Z-1916-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1916-2018%22&limit=1).

Synthes (USA) Products LLC recalled the Synthes Torque Limiting Handle, Part Number 03.231.013, because the adapter may demonstrate a degradation of function due to ball bearings likely to rust prematurely, according to the FDA. The agency announced the voluntary Class II recall on May 4, 2018.

How to tell if you have it

Brand: Synthes
Product: Synthes Torque Limiting Handle
Part Number: 03.231.013
Lot Codes: H344006-02 through H344006-41, H344006-43, H344006-45 through H344006-49, H369323-03, H369323-04
Distribution: USA (nationwide); states include AK, CA, FL, ID, IN, KS, KY, LA, MD, MI, MT, NC, NJ, NY, OH, OK, PA, SD, TN, TX, UT, WI, and WV

The hazard

The device is used in systems indicated for fracture fixation. The adapter may demonstrate a degradation of function because the final products were assembled with ball bearings of high carbon content that is likely to rust prematurely.

Context

GovInfoNow's records show Synthes (USA) Products LLC has 19 other recalls on record since July 21, 2017. Other recent recalls of similar products include Synthes 2.4V TAP CORTEX SCREW Recall: Incorrect Thread Hazard (Feb. 25, 2026), Synthes LOW PROF LCKNG SCREW: Incorrect Length Labeling on Packaging (Sept. 26, 2025), and Synthes Stardrive Screwdrivers May Cause Surgical Delay - Recall (April 25, 2024).

How to tell if you have this one

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.

Brand
Synthes
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Handle Part Number
Look for part number 03.231.013 on the handle to confirm if it is recalled.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 23 states.

FDA distribution: “USA (nationwide) Distribution to the states of : AK, CA, FL, ID, IN, KS, KY, LA, MD, MI, MT, NC, NJ, NY, OH, OK, PA, SD, TN, TX, UT, WI, and WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alaska, California, Florida, Idaho, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Montana, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Utah, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 18 months after the firm started it.

May 4, 2018Firm started the recall
May 23, 2018FDA classified it Class II
May 30, 2018Published in FDA’s Enforcement Report
Oct 21, 2019FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this handle safe to use?

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.

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Link to this recall

<a href="https://govinfonow.com/recall/71203-synthes-torque-handle-recall-rust-risk-in-fracture-fixation-devices">Synthes Torque Handle Recall: Rust Risk in Fracture Fixation Devices (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1916-2018 (May 4, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1916-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.