FDA Device recall Z-0442-2019
3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack
- FDA Device
- Class II
- ongoing
- Published 2018-11-21
On 2018-11-21 the FDA classified a Class II recall of 3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack by Arthrex, citing there is potential to break during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0442-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-09-13 |
| Published | 2018-11-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Arthrex |
| Distribution | US |
Product
3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant. Contents include: Actuation Driver, 6.2mm Reamer, 3.2mm Reamer, 2 mm Drill, Spade Tip Guide Wire, and 1.6mm x 12 K-Wire.
Reason
There is potential to break during use.
Identifiers
| code_info | Part #ST6100, Lot/Serial #'s: A251217-04, A011217-01, A011217-03, A091017-05, A101017-01, A111017-01, A121017-01, A1210…Part #ST6100, Lot/Serial #'s: A251217-04, A011217-01, A011217-03, A091017-05, A101017-01, A111017-01, A121017-01, A121017-02, A131017-01, A140917-01, A161017-01, A171017-01, A181017-07, A221117-01, A271117-01, A281117-02, A291117-01, A291117-03, A301117-01, A281117-01. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0442-2019%22
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