# FDA recall Z-0391-2020

> **Orthofix Srl** · Class II · device recall initiated 2018-09-27.

## Product

ORTHOFIX Catalogue Number: ref: 99-92502,   PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX ONLY, UDI: (01) 18033509855955

## 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.

## Distribution

US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico   OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel

## Key facts

- **Recall number:** Z-0391-2020
- **Recalling firm:** Orthofix Srl
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-27
- **Report date:** 2019-11-20
- **Termination date:** 2022-02-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Veronaverona, N/A, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0391-2020

## Citation

> AI Analytics. FDA recall Z-0391-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0391-2020. Source: US FDA. Licensed CC0.

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