Z-0586-2021Class II

DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code...

Name: Z-0586-2021 DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code...
Creator: Synthes (USA) Products LLC
Published: 2020-11-19
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2020-11-19 / Terminated

FDA source

Synthes (USA) Products LLC began a recall of DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.031S on 2020-11-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0586-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-19
Posted: 2020-12-15
Terminated: 2022-07-01
Recalling firm: Synthes (USA) Products LLC
Product: DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.031S
Product code: HTO Reamer
Reason for recall: 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
FDA root cause: Use error
Action: DePuy Synthes issued voluntary device correction letter on 11/19/202 via 2-day by Fed Ex, stating reason for recall, health risk and action to take: This safety notification is advising physicians of the following supplemental information regarding the surgical approach of standard IM nail reaming as referred to in the surgical technique guide. Open the medullary canal and conduct reaming by following AO reaming techniques for IM nailing and maintain a guide wire entry angle of less than 10 from the axis of the canal. CAUTION: If the guide wire entry angle is greater than 10 from the axis of the canal, there is a risk that bowing of the reaming rod will result in: o Eccentric reaming of the far cortex o Damage to the reamer head connection, resulting in metal fragments in the canal NOTE: " For an antegrade femoral approach, if possible, adduct the limb/hip to facilitate access to entry point. For greater trochanter entry point, target >2cm distal to the lesser trochanter1. " For an antegrade tibial approach, the knee will need to be flexed to 90-110 for entry site access. Insert the guide wire aiming down the tibial crest, and thus the center of the medullary canal Please take the following actions: " Forward this notice to anyone in your facility that needs to be informed. " If any of the subject product has been forwarded to another facility, contact that facility. " Keep a copy of this notice with the subject product. " Identify and discard any current Printed Surgical Technique. " To get the updated version visit our website: https://www.jnjmedicaldevices.com/en-US/product/ria-2-system-reamer-irrigator-aspirator " Review, complete, sign, and return the attached reply form on page 4 of this letter to your local sales organization in accordance with the directions on the form within 5-business days of receipt of this notification. " Should you have any inquiries please do not hesitate to contact your sales consultant " This letter
Quantity in commerce: 515 US; 150 OUS
Distribution: Nationwide Foreign:countries: United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, United Kingdom, Ireland, Israel, Italy, Singapore,
Product codes and lots: All Lots UDI: 10886982274076

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0586-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0571-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-15
Z-0572-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-15
Z-0573-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-15
Z-0574-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-15
Z-0575-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-15
Z-0576-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-15
Z-0577-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-15
Z-0578-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-15
Z-0579-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-15
Z-0580-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-15
Z-0581-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-15
Z-0582-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-15
Z-0583-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-15
Z-0584-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-15
Z-0585-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-15
Z-0586-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-15
Z-0587-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-15

Product code HTO

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)