FDA Device recall Z-2638-2020
DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the pla…
- FDA Device
- Class II
- terminated
- Published 2020-07-22
On 2020-07-22 the FDA classified a Class II recall of DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the pla… by Neocis, citing the LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2638-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-14 |
| Published | 2020-07-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Neocis |
| Distribution | US |
Product
DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
Reason
The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
Identifiers
| code_info | Work Order (lot): 1616, 1621, and 1622 |
|---|
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-2638-2020%22
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