Device recall: DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code: 03.404.016S
Class II FDA enforcement event 86713. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Synthes (USA) Products LLC started this device recall on 19 Nov 2020. The firm address in the FDA record is in West Chester, PA. FDA put the recall in Class II. FDA event 86713 has 17 product records. The first FDA enforcement report date is 23 Dec 2020. The record gives the status Terminated, with the termination date 1 Jul 2022.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide Foreign:countries: United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, United Kingdom, Ireland, Israel, Italy, Singapore,
Recalling firm
Synthes (USA) Products LLC, West Chester, PA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
17 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0571-2021 | DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code: 03.404.016S | 1297 US 528 OUS | Class II | Terminated | 23 Dec 2020 |
| Z-0572-2021 | DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.017S | 1066 US; 397 OUS | Class II | Terminated | 23 Dec 2020 |
| Z-0573-2021 | DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.018S | 1275 US and 445 OUS | Class II | Terminated | 23 Dec 2020 |
| Z-0574-2021 | DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S | 1231US; 422 OUS | Class II | Terminated | 23 Dec 2020 |
| Z-0575-2021 | DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S | 1566 US ; 732 OUS | Class II | Terminated | 23 Dec 2020 |
| Z-0576-2021 | DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.021S | 1337 US; 453 OUS | Class II | Terminated | 23 Dec 2020 |
| Z-0577-2021 | DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.022S | 1447 US; 554 OUS | Class II | Terminated | 23 Dec 2020 |
| Z-0578-2021 | DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.023S | 1262 US; 549 OUS | Class II | Terminated | 23 Dec 2020 |
| Z-0579-2021 | DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.024S | 1328 US ; 578 OUS | Class II | Terminated | 23 Dec 2020 |
| Z-0580-2021 | DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.025S | 1142 US; 450 OUS | Class II | Terminated | 23 Dec 2020 |
| Z-0581-2021 | DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.026S | 748 US; 381 OUS | Class II | Terminated | 23 Dec 2020 |
| Z-0582-2021 | DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.027S | 642 US; 325 OUS | Class II | Terminated | 23 Dec 2020 |
| Z-0583-2021 | DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S | 651US : 326 OUS | Class II | Terminated | 23 Dec 2020 |
| Z-0584-2021 | DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.029S | 531 US; 317 OUS | Class II | Terminated | 23 Dec 2020 |
| Z-0585-2021 | DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.030S | 572 US; 200 OUS | Class II | Terminated | 23 Dec 2020 |
| Z-0586-2021 | DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.031S | 515 US; 150 OUS | Class II | Terminated | 23 Dec 2020 |
| Z-0587-2021 | DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.032S | 542 US ; 154 OUS | Class II | Terminated | 23 Dec 2020 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2020
- 916
- Share of these events in Class II
- 93%
- Product records in this event
- 17Median of the firm: 1
- Events of the firm on the register
- 72
Other events of the firm
Official channels
- FDA enforcement report Z-0571-2021The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 86713. https://recallregister.com/fda/ii/86713/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide Foreign:countries: United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, United Kingdom, Ireland, Israel, Italy, Singapore,
- What quantity of product is in FDA event 86713?
- The event has 17 product records. The first record gives this quantity:
1297 US 528 OUS
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2020 have the same class?
- 93% of the 916 device events that started in 2020 are in Class II.