BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3 — Class II medical device recall Z-0591-2020
Terminated recall by Brasseler USA I Lp, reported 2019-12-11, distributed nationwide. One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.
| Recall number | Z-0591-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brasseler USA I Lp, Savannah, GA, United States |
| Recall initiated | 2019-10-18 |
| Classified | 2019-12-02 |
| Reported by FDA | 2019-12-11 |
| Terminated | 2020-12-14 |
| Distributed | Nationwide (US) |
| Quantity | 387 units |
| Lot numbers | NR1VM |
Product
BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill into bone in hip or knee surgeries.
Reason for recall
One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.
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-0591-2020. 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.