ImplantDirect recall
ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit…
Why was ImplantDirect recalled?
The main vial label lists the incorrect part number, but the cap label is correct.
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?
Lot #87837
- Product
- ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit…
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Quantity
- 124 units
- Distribution
- Distribution was made to AZ, CA, CO, CT, FL, ID, IL, NC, NJ, NV, NY, PA, TX, UT, VA, and WA. There was no government/military distribution. Foreign distribution was made to Switzerland, Germany, Lithuania, and Spain.
- Recall date
- August 1, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)