DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL recall: Labeling Error
DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning…
Why was DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL recalled?
The LRUL and LLUR posterior chairside splints and 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): 1616, 1621, and 1622
- Product
- DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning…
- Recalling firm
- Neocis Inc.
- Quantity
- 70 units
- Distribution
- US Nationwide distribution including in the states of AZ, CA, FL, NY, and NH
- Recall date
- July 22, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)