DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL — Class II medical device recall Z-0929-2021
Terminated recall by Neocis, Inc., reported 2021-02-03, distributed in AZ, CT, FL, MA, NY, OH, PA. The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled.
| Recall number | Z-0929-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Neocis, Inc., Miami, FL, United States |
| Recall initiated | 2020-10-30 |
| Classified | 2021-01-26 |
| Reported by FDA | 2021-02-03 |
| Terminated | 2021-08-11 |
| Distributed | AZ, CT, FL, MA, NY, OH, PA |
| Quantity | 100 units |
| Reason classes | labeling |
| Lot numbers | 1573 |
Product
DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)
Reason for recall
The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0929-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.