FDA Device recall Z-1311-2020
Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy pr…
- FDA Device
- Class II
- terminated
- Published 2020-02-26
On 2020-02-26 the FDA classified a Class II recall of Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy pr… 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-1311-2020 |
| 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
Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
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)07332747065589(10)73287 (01)07332747065589(10)73428 Catalog# 37085 |
|---|
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-1311-2020%22
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