Implant Direct recall
Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
Why was Implant Direct recalled?
A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.
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 #135128 Exp: 3/12/20
- Product
- Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Quantity
- 23 implants
- Distribution
- U.S.: IN, VA, MD, TX, WA OUS: Japan
- Recall date
- November 20, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)