FDA Device recall Z-0658-2022
NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
- FDA Device
- Class II
- terminated
- Published 2022-03-02
On 2022-03-02 the FDA classified a Class II recall of NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R by Nobel Biocare Usa, citing due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0658-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-12-17 |
| Published | 2022-03-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Nobel Biocare Usa |
| Distribution | US |
Product
NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Reason
Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure.
Identifiers
| code_info | Catalog Number: 36707 UDI Code: (01)07332747160529(10)13116495(11)210720(17)260618; (01)07332747160529(10)13116496(11)2…Catalog Number: 36707 UDI Code: (01)07332747160529(10)13116495(11)210720(17)260618; (01)07332747160529(10)13116496(11)210720(17)260618; (01)07332747160529(10)13116497(11)210720(17)260618; Lot Numbers: 13116495, 13116496, 13116497 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0658-2022%22
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