FDA Device recall Z-2375-2016
Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connec…
- FDA Device
- Class II
- terminated
- Published 2016-08-17
On 2016-08-17 the FDA classified a Class II recall of Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connec… by Nobel Biocare Usa, citing incorrect drill protocol in the Instructions for Use (IFU).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2375-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-20 |
| Published | 2016-08-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Nobel Biocare Usa |
| Distribution | US |
Product
Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", id # 2002 and Manual: Guided Surgery with NobelParallel Conical Connection", id # 79423. Article # 38072, Nobel Parallel CC Guided Surgery Kit. The Guided Surgery Kit is used as part of the installation process of NobelParallel CC Implants. The purpose of the IFU is to instruct the user how to use the products safely. The purpose of the manual is to guide the user through the usage of NobelGuide for NobelParallel CC.
Reason
Incorrect drill protocol in the Instructions for Use (IFU)
Identifiers
| code_info | Article 38072-all lots |
|---|
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-2375-2016%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.