Replace Select Tapered TiU NP 3 — Class II medical device recall Z-2237-2016
Terminated recall by Nobel Biocare Usa Llc, reported 2016-07-27, distributed in NY, OH, OR. Incorrect top label on an implant package.
| Recall number | Z-2237-2016 |
|---|---|
| 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 | 2016-06-22 |
| Classified | 2016-07-19 |
| Reported by FDA | 2016-07-27 |
| Terminated | 2016-09-06 |
| Distributed | NY, OH, OR |
| Countries outside the US | BR, TW |
| Reason classes | labeling |
Product
Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function.
Reason for recall
Incorrect top label on an implant package.
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-2237-2016. 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.