CLASS II Device recall · Reported 23 Dec 2020 · FDA Enforcement Report
DePuy Synthes Reamer Head For Ria 2 Sterile-Orthopedic recalled
Synthes (USA) Products is recalling DePuy Synthes Reamer Head For Ria 2 Sterile-Orthopedic manual surgical instrument Part, distributed nationwide in the US. The recall was initiated on 19 Nov 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0587-2021
- FDA event ID
- 86713
- Recalling firm
- Synthes (USA) Products, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Nov 2020
- FDA classified
- 15 Dec 2020
- Reported
- 23 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 19 Nov 2020 | Recall initiated by company | |
| 15 Dec 2020 | Classified by FDA | +26 days |
| 23 Dec 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.032S
Where it was distributed
Nationwide Foreign:countries: United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, United Kingdom, Ireland, Israel, Italy, Singapore,
Questions about this recall
Is DePuy Synthes Reamer Head For Ria 2 Sterile-Orthopedic manual surgical instrument Part recalled?
Yes. Synthes (USA) Products recalled DePuy Synthes Reamer Head For Ria 2 Sterile-Orthopedic manual surgical instrument Part on 19 Nov 2020. The recall is Class II and its status is Terminated. Recall number Z-0587-2021.
Why was it recalled?
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
Which lots are affected?
All Lots UDI: 10886982274090
Where was it sold?
Nationwide Foreign:countries: United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, United Kingdom, Ireland, Israel, Italy, Singapore,
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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