The Recall Desk
ModerateFDA (Devices)·Z-2638-2020·Announced 2020-07-22

Neocis Dental Chairside Splints Recalled for Potential Mislabeling

Neocis Inc. is recalling 70 units of Gen 2 Posterior Chairside Splints due to potential mislabeling. The affected products are used in dental implantation surgery.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error (mislabeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Neocis Inc. is recalling 70 units of the DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left). These medical devices are intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.

The recall was initiated because the LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. The affected units are associated with Work Order (lot) numbers 1616, 1621, and 1622.

The products were distributed nationwide in the United States, including in the states of Arizona, California, Florida, New York, and New Hampshire. Consumers and healthcare providers should stop using the affected products and contact Neocis Inc. for further instructions.

The recalled product

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.
Manufacturer
Neocis Inc.
Affected units
70

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Work Order (lot): 1616
  • 1621
  • and 1622

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Neocis Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →