FDA Device recall Z-0973-2013
PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework
- FDA Device
- Class II
- terminated
- Published 2013-03-27
On 2013-03-27 the FDA classified a Class II recall of PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework by Keystone Dental, citing mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0973-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-11 |
| Published | 2013-03-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Keystone Dental |
| Distribution | CA, DC, FL, IN, MA, MN, NH, NJ, NY, PA, WI |
Product
PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
Reason
Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled
Identifiers
| code_info | Lot Number: 12857 |
|---|
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-0973-2013%22
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