FDA Device recall Z-0377-2020
ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (01)18032568031911
- FDA Device
- Class II
- terminated
- Published 2019-11-20
On 2019-11-20 the FDA classified a Class II recall of ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (01)18032568031911 by Orthofix Srl, citing 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 i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0377-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-27 |
| Published | 2019-11-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Orthofix Srl |
| Distribution | 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 |
Product
ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (01)18032568031911
Reason
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.
Identifiers
| code_info | Lot # B1202045, B1206643, B1218524, 273351 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0377-2020%22
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