DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL recall: Labeling Error
DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)
Why was DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL recalled?
The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Work Order (Lot) Number 1573
- Product
- DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)
- Recalling firm
- Neocis, Inc.
- Quantity
- 100 units
- Distribution
- OH, FL, CT, MA, AZ PA, NY
- Recall date
- February 3, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)