RecallRadar

FDA Device recall Z-0929-2021

DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left)

On 2021-02-03 the FDA classified a Class II recall of DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left) by Neocis, citing the LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0929-2021
ClassificationClass II
Statusterminated
Initiated2020-10-30
Published2021-02-03
Last updated2026-09-13 11:56 UTC
CompanyNeocis
DistributionAZ, CT, FL, MA, NY, OH, PA

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

The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled.

Identifiers

code_infoWork Order (Lot) Number 1573

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0929-2021%22

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