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.
FDA Recall Z-2637-2020 · Posted None
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Recalling FirmNeocis Inc.
Recall StatusTerminated
Product CodePLV
Date Initiated2020-05-14
Date Terminated2021-07-27
Product Quantity70 units
Reason for Recall
The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
Firm 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.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution including in the states of AZ, CA, FL, NY, and NH
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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