DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL — Class II medical device recall Z-2638-2020
Terminated recall by Neocis Inc., reported 2020-07-22, distributed nationwide. The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
| Recall number | Z-2638-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Neocis Inc., Miami, FL, United States |
| Recall initiated | 2020-05-14 |
| Classified | 2020-07-16 |
| Reported by FDA | 2020-07-22 |
| Terminated | 2021-07-27 |
| Distributed | Nationwide (US) |
| Quantity | 70 units |
| Reason classes | labeling |
| Lot numbers | 1616, 1621, 1622, DRW-0739-02 |
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 for recall
The LRUL and LLUR posterior chairside splints and 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-2638-2020. 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.