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Neocis, Inc. Recall 87060

Description: DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)

Neocis, Inc. Recall 87060 Information

StatusTerminated
Mandated?Voluntary: Firm initiated
Recall NumberZ-0929-2021
Event ID87060
Event DescriptionDRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)
Product TypeDevices
DistributionOH, FL, CT, MA, AZ PA, NY
Quantity100 units
Recall ReasonThe LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled.
Device Classification20210203
Device Code InfoWork Order (Lot) Number 1573
Center Classification Date20210126
Recall Initiation Date20201030
Recalling FirmNeocis, Inc.
Initial Notification Letter
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