ORTHOFIX Catalogue Number: ref: 99-93502 — Class II medical device recall Z-0397-2020
Terminated recall by Orthofix Srl, reported 2019-11-20, distributed in AZ, CA, FL, GA, HI, IA, IL, IN…. As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail
| Recall number | Z-0397-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthofix Srl, Veronaverona, N/A, Italy |
| Recall initiated | 2018-09-27 |
| Classified | 2019-11-14 |
| Reported by FDA | 2019-11-20 |
| Terminated | 2022-02-01 |
| Distributed | AZ, CA, FL, GA, HI, IA, IL, IN, KY, LA, MD, MI, MO, MS, NC, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV |
| Countries outside the US | AE, AU, BE, BR, CH, CL, DE, DK, ES, FR, GB, IE, IL, IT, JP, KW, LK, LT, NL, PE, PL, SA, SG, ZA |
| UPC / GTIN / UDI-DI | 18033509859915 |
| Lot numbers | B1200709, B1204115, B1206439, B1225414, B1233729 |
| Model numbers | 99-93502 |
Product
ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)18033509859915
Reason for recall
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
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-0397-2020. 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.