NobelReplace CC PMC RP 5 — Class II medical device recall Z-1440-2015
Terminated recall by Nobel Biocare Usa Llc, reported 2015-04-22, distributed nationwide. A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of t
| Recall number | Z-1440-2015 |
|---|---|
| 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 | 2015-03-09 |
| Classified | 2015-04-13 |
| Reported by FDA | 2015-04-22 |
| Terminated | 2015-12-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, CA, CH, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IT, LT, LU, MX, NL, NO, PL, PT, RO, SA, SE, TR |
| Quantity | 38 units |
| Lot numbers | 13010296 |
Product
NobelReplace CC PMC RP 5.0x13mm, Article No. 37298.
Reason for recall
A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
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-1440-2015. 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.