ImplantDirect recall: Labeling Error
ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
Why was ImplantDirect recalled?
Packaged dental implant contains a different size then the size declared on the labeling.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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 # 166300 / UDI: 10841307101796
- Product
- ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
- Recalling firm
- Implant Direct Sybron Manufacturing LLC
- Quantity
- 83 implants
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, CA, HI, IL, KS, LA, MA, MD, MI, MO, MT, NE, NJ, NY, OH, OR, PA, RI, SC, TX, UT, VA, WA, WI and the country of Japan.
- Recall date
- November 10, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)