ACTIS Flex Reamers SZ 0/1 — Class II medical device recall Z-0650-2017
Terminated recall by Depuy Orthopaedics Inc., reported 2016-11-30, distributed in CA, KY, LA, MD, ME, NC, NH, NY…. DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers due to the instr
| Recall number | Z-0650-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Depuy Orthopaedics Inc., Warsaw, IN, United States |
| Recall initiated | 2016-10-25 |
| Classified | 2016-11-21 |
| Reported by FDA | 2016-11-30 |
| Terminated | 2017-06-06 |
| Distributed | CA, KY, LA, MD, ME, NC, NH, NY, TX, VA, WA |
| Countries outside the US | AT, IE, JP |
| Quantity | 137 |
| UPC / GTIN / UDI-DI | 10603295434818, 10603295434825, 10603295434832, 10603295434849, 10603295434856, 10603295434863, 10603295434870 |
Product
ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFU
Reason for recall
DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers due to the instruments breaking and potentially leaving pieces in the patient.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0650-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.