Implant Direct recall
Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
Why was Implant Direct recalled?
packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.
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 numbers 120197; Exp. 07/16/2023 and 120198; Exp. 07/19/2023
- Product
- Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Quantity
- 53 implants
- Distribution
- US distribution in the states of: CA, UT, VA, NY, IL, AR, TX, OH, NV, FL, ID, AK, NC, KS, MN, AZ, CO,
- Recall date
- November 20, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)