FDA Device recall Z-2119-2012
Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total Shoulder Arthroplasty
- FDA Device
- Class II
- terminated
- Published 2012-08-08
On 2012-08-08 the FDA classified a Class II recall of Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total Shoulder Arthroplasty by Exactech, citing exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Inte….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2119-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-15 |
| Published | 2012-08-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Exactech |
| Distribution | AL, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OK, OR, PA, TN, TX, VA, WA |
Product
Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Reason
Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year
Identifiers
| code_info | Catalog Number 324-15-05 Serial Range 1620549-2381151 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2119-2012%22
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