FDA Device recall Z-1319-2020
Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection has b…
- FDA Device
- Class II
- terminated
- Published 2020-02-26
On 2020-02-26 the FDA classified a Class II recall of Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection has b… by Nobel Biocare Usa, citing due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1319-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-14 |
| Published | 2020-02-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Nobel Biocare Usa |
| Distribution | US |
Product
Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
Reason
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Identifiers
| code_info | (01)07332747083798(10)73614 (01)07332747083798(10)73256 Catalog# 37474 |
|---|
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-1319-2020%22
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