FDA Device recall Z-0900-2017
Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
- FDA Device
- Class II
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class II recall of Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit by Exactech, citing disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0900-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-25 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Exactech |
| Distribution | US |
Product
Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
Reason
Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.
Identifiers
| code_info | Catalog No. 320-20-00; Unique Device Identifier 10885862086518; Serial Range 4410696-4410819, 4415393-4415492, 4418789-…Catalog No. 320-20-00; Unique Device Identifier 10885862086518; Serial Range 4410696-4410819, 4415393-4415492, 4418789-4418888, 4422658-4423007, 4423542-4423591, 4424509-4424558, 4458153-4458252, 4458303-4458352, 4461732-4461806, 4464592-4464691, 4467733-4467824, 4471099-4471298, 4485494-4485543, 4488224-4488260, 4504738-4504987, 4513150-4513199, 4513250-4513299, 4517116-4517215, 4519806-4520005, 4533291-4533390, 4542043-4542092. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Exactech
- Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
FDA Device · Class II · 2026-03-18 · Exactech - Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
FDA Device · Class II · 2026-03-18 · Exactech - Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product De…
FDA Device · Class II · 2025-11-26 · Exactech - Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Des…
FDA Device · Class II · 2025-11-26 · Exactech - Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product De…
FDA Device · Class II · 2025-11-26 · Exactech
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0900-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.