FDA Device recall Z-3171-2017
ECT Internal Fracture Fixation Drill Bits 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803206, Nonsterile. orthopedic surgical instrum…
- 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 Drill Bits 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803206, Nonsterile. orthopedic surgical instrum… 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-3171-2017 |
| 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 Drill Bits 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803206, 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 Numbers: 63556703, 63566220, 63593926, 63593928, 63593930, 63630281, 63340536, 63340537, 63347015, 63347018, 63347…Lot Numbers: 63556703, 63566220, 63593926, 63593928, 63593930, 63630281, 63340536, 63340537, 63347015, 63347018, 63347022, 63347034, 63358186, 63358201, 63372867, 63398739, 63398761, 63398762, 63426475, 63426476, 63426478, 63431754, 63431755, 63457862, 63457863, 63457865, 63457889, 63474135, 63479010, 63479011, 63479013, 63524442, 63524443 & 63524445. |
|---|
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-3171-2017%22
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