FDA Medical Device Recalls (openFDA)
Neocis Inc.: DRW-0739-01: Gen 2 Posterior 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.
- Recall number
- Z-2637-2020
- Recalling firm
- Neocis Inc.
- Product
- DRW-0739-01: Gen 2 Posterior 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.
- Status
- Terminated
- Initiated
- 2020-05-14
- Posted
- not on file
- Terminated
- 2021-07-27
- Reason
- The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
- Root cause
- Process control
- Action
- Customers were notified via UPS overnight mail sent 05/19/2020. Notification also included a site visit from the Neocis Clinical Sales Representative or Neocis Field Clinical Engineer. Customers are asked to stop use of the Gen II Posterior Splints until a trained person from Neocis has inspected their inventory. 100% effectiveness checks are planned.
- Quantity
- 70 units
- Distribution
- US Nationwide distribution including in the states of AZ, CA, FL, NY, and NH
- Lot, serial or model codes
- Work Order (lot): 1619 and 1620
- 510(k) numbers
- ["K173402"]
- PMA numbers
- not on file
- Product code
- PLV
- Firm FEI
- 3012787974
- Firm city
- Miami
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28