3 — Class II medical device recall Z-0442-2019
Ongoing recall by Arthrex, Inc., reported 2018-11-21, distributed nationwide. There is potential to break during use.
| Recall number | Z-0442-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arthrex, Inc., Naples, FL, United States |
| Recall initiated | 2018-09-13 |
| Classified | 2018-11-09 |
| Reported by FDA | 2018-11-21 |
| Distributed | Nationwide (US) |
| Quantity | 832 |
| Reason classes | device malfunction |
| Serial numbers | 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, A251217-04, A271117-01, A281117-01, A281117-02, A291117-01, A291117-03, A301117-01 |
| Model numbers | ST6100 |
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 for recall
There is potential to break during use.
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-0442-2019. 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.