FDA Device recall Z-2535-2016
Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512
- FDA Device
- Class II
- terminated
- Published 2016-08-24
On 2016-08-24 the FDA classified a Class II recall of Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512 by Straumann Manufacturing, citing misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2535-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-14 |
| Published | 2016-08-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Straumann Manufacturing |
| Distribution | US |
Product
Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512
Reason
Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration
Identifiers
| code_info | Lot Number: LT123 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2535-2016%22
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