FDA Device recall Z-3156-2017
ECT Internal Fracture Fixation Long Drill, 6.4 mm (1/4 Inch) Diameter 20.3 cm(8 Inch) Length, Item Number/EDI 00129100406, Nonsterile. orth…
- FDA Device
- Class II
- terminated
- Published 2017-10-04
On 2017-10-04 the FDA classified a Class II recall of ECT Internal Fracture Fixation Long Drill, 6.4 mm (1/4 Inch) Diameter 20.3 cm(8 Inch) Length, Item Number/EDI 00129100406, Nonsterile. orth… by Zimmer Biomet, citing 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 increa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3156-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-22 |
| Published | 2017-10-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
ECT Internal Fracture Fixation Long Drill, 6.4 mm (1/4 Inch) Diameter 20.3 cm(8 Inch) Length, Item Number/EDI 00129100406, Nonsterile. orthopedic surgical instrument.
Reason
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.
Identifiers
| code_info | Lot Number: 63517946 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3156-2017%22
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