ECT Internal Fracture Fixation Drill 1 — Class II medical device recall Z-3148-2017
Terminated recall by Zimmer Biomet, Inc., reported 2017-10-04, distributed nationwide. Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with
| Recall number | Z-3148-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-05-22 |
| Classified | 2017-09-22 |
| Reported by FDA | 2017-10-04 |
| Terminated | 2019-03-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CN, DE, GT, IN, JP, KR, MX, MY, NL, PA, SG, SV, TT, TW |
| Quantity | 751 units |
| Reason classes | device malfunction |
| Lot numbers | 63398756, 63415316, 63444654, 63462301, 63474169, 63485122, 63485126, 63496894, 63505359, 63530405, 63530406, 63574373, 63622721 |
| Model numbers | 00231801100 |
Product
ECT Internal Fracture Fixation Drill 1.1 mm Diameter (.043 Inch), Item Number/EDI 00231801100, Nonsterile. orthopedic surgical instrument.
Reason for recall
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
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-3148-2017. 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.