Instructions for Use — Class II medical device recall Z-2375-2016
Terminated recall by Nobel Biocare Usa Llc, reported 2016-08-17, distributed nationwide. Incorrect drill protocol in the Instructions for Use (IFU)
| Recall number | Z-2375-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nobel Biocare Usa Llc, Yorba Linda, CA, United States |
| Recall initiated | 2016-07-20 |
| Classified | 2016-08-09 |
| Reported by FDA | 2016-08-17 |
| Terminated | 2016-10-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, DE, DK, ES, FR, GB, IT, NL, NO, PL, PT, RU, TR |
| Quantity | 231 kits |
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 for recall
Incorrect drill protocol in the Instructions for Use (IFU)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2375-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.