DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.
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📍Recalling firmSynthes (USA) Products LLC1301 Goshen Pkwy · West Chester, PA 19380-5986
“Synthes Radial Head Replacement System: Contraindications Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60833-synthes-radial-head-replacement-system-contraindications-risk. Based on FDA recall #Z-1072-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1072-2022%22&limit=1).
The FDA announced on April 7, 2022, that Synthes (USA) Products LLC is recalling the Radial Head Replacement System implant due to contraindications added to its electronic instructions for use. The agency stated that absolute contraindications include infection, sepsis, and osteomyelitis.
The recall involves the addition of absolute contraindications to the Electronic Instructions for Use (e-IFU) for the DePuy Synthes Radial Head Replacement System. These contraindications include infection, sepsis, and osteomyelitis.
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 Stardrive Screwdrivers May Cause Surgical Delay - Recall (April 25, 2024), Synthes LOW PROF LCKNG SCREW: Incorrect Length Labeling on Packaging (Sept. 26, 2025), and Synthes 2.4V Tap Locking Screw Tap Recall: Incorrect Thread Hazard (Feb. 25, 2026). Other recent recalls of similar products include TMJ Bilateral Implants Recall: Risk of Poor Fit Causing Open Bite (Feb. 11, 2026), Arrowhead Implant Recall: Potential Infection Risk from Sterility Issues (June 23, 2026), and Straumann GM Helix Dental Implant Recall: Packaging Mismatch Risk (July 13, 2026).
How to tell if you have this one
Check for the product names: Radial Head Replacement System Implant. Look for serial numbers listed in the recall notice, which include specific model numbers like 03.405.000S and 09.405.250S.
Brand
Synthes
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check for Contraindications
If you have an infection, sepsis, or osteomyelitis, do not use this implant.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1072-2022 (April 7, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1072-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.