DePuy Synthes 12.0MM Reamer Head Recall: Breakage Risk with Surgical Use
DePuy Synthes recalls 12.0MM reamer heads for RIA 2 surgical use due to breakage risk when improper techniques are applied, potentially causing tissue damage.
Use caution until it’s fixed
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed
Contact the company
What happened, in plain English
DePuy Synthes is recalling 12.0MM reamer heads for RIA 2 surgical procedures because they can break more often than expected if used incorrectly, leading to tissue damage or bone injury. This affects orthopedic surgeons and their patients during specific surgeries. Read more at govinfonow.com/recall/63832-depuy-synthes-12-0mm-reamer-head-recall-breakage-risk-with.
Source Summary by GovInfoNow · govinfonow.com/recall/63832-depuy-synthes-12-0mm-reamer-head-recall-breakage-risk-with · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0575-2021
Cite this page
“DePuy Synthes 12.0MM Reamer Head Recall: Breakage Risk with Surgical Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63832-depuy-synthes-12-0mm-reamer-head-recall-breakage-risk-with. Based on FDA recall #Z-0575-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0575-2021%22&limit=1).
Why it’s dangerous
The reamer head can break more frequently than normal when surgical techniques aren't followed correctly. This breakage may cause tissue damage, soft tissue injury, or bone damage during procedures.
Who’s affected
Orthopedic surgeons and patients undergoing RIA 2 procedures using this specific reamer head. Surgeons using improper techniques are at higher risk of complications.
How to tell if you have this one
Check for the part code 03.404.020S on the reamer head. All lots of this product are affected, with a unique device identifier (UDI) of 10886982273987.
- Brand
DePuy Synthes- Category
Medical device
All 17 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide Foreign:countries: United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, United Kingdom, Ireland, Israel, Italy, Singapore,
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0571-2021 | DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code: 03.404.016S; All Lots UDI: 10886982273932 | 1297 US 528 OUS |
| Z-0572-2021 | DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.017S; All Lots UDI: 10886982273949 | 1066 US; 397 OUS |
| Z-0573-2021 | DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.018S; All Lots UDI: 10886982273963 | 1275 US and 445 OUS |
| Z-0574-2021 | DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S; All Lots UDI: 10886982273970 | 1231US; 422 OUS |
| Z-0575-2021 | DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S; All Lots UDI: 10886982273987 | 1566 US ; 732 OUS |
| Z-0576-2021 | DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.021S; All Lots UDI: 10886982274007 | 1337 US; 453 OUS |
| Z-0577-2021 | DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.022S; All Lots UDI: 10886982274021 | 1447 US; 554 OUS |
| Z-0578-2021 | DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.023S; All Lots UDI: 10886982274045 | 1262 US; 549 OUS |
| Z-0579-2021 | DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.024S; All Lots UDI: 10886982274069 | 1328 US ; 578 OUS |
| Z-0580-2021 | DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.025S; All Lots UDI: 10886982274083 | 1142 US; 450 OUS |
| Z-0581-2021 | DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.026S; All Lots UDI: 10886982273956 | 748 US; 381 OUS |
| Z-0582-2021 | DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.027S; All Lots UDI:10886982273994 | 642 US; 325 OUS |
| Z-0583-2021 | DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S; All Lots UDI: 10886982274014 | 651US : 326 OUS |
| Z-0584-2021 | DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.029S; All Lots UDI: 10886982274038 | 531 US; 317 OUS |
| Z-0585-2021 | DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.030S; All Lots UDI: 10886982274052 | 572 US; 200 OUS |
| Z-0586-2021 | DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.031S; All Lots UDI: 10886982274076 | 515 US; 150 OUS |
| Z-0587-2021 | DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.032S; All Lots UDI: 10886982274090 | 542 US ; 154 OUS |
What to do — step by step
Check for Breakage
Inspect the reamer head for signs of damage or unusual wear that might indicate breakage risk.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide Foreign:countries: United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, United Kingdom, Ireland, Israel, Italy, Singapore,” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0575-2021 (November 19, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0575-2021 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.