FDA Device recall Z-2828-2020
NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower ja…
- FDA Device
- Class II
- terminated
- Published 2020-08-26
On 2020-08-26 the FDA classified a Class II recall of NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower ja… by Nobel Biocare Services Ag, citing dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lea….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2828-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-20 |
| Published | 2020-08-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Nobel Biocare Services Ag |
| Distribution | US |
Product
NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.
Reason
Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second surgical procedure; 2) Implant replacement; 3) If placed in posterior lower jaw, the implant may damage the inferior alveolar nerve canal or perforate a small artery requiring immediate implant removal.
Identifiers
| code_info | Lot: 13084072, UDI: (01)07332747073584(10)13084072(17)240525 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2828-2020%22
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