Data Foundry

Medical device recalls 2020

DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR — Class II medical device recall Z-2639-2020

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 numberZ-2639-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmNeocis Inc., Miami, FL, United States
Recall initiated2020-05-14
Classified2020-07-16
Reported by FDA2020-07-22
Terminated2021-07-27
DistributedNationwide (US)
Quantity50 units
Reason classeslabeling
Lot numbers1623, DRW-0742-01

Product

DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - 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-2639-2020. 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.