medical Class II Updated 2019-11-20

Implant Direct Sybron Manufacturing, LLC recalls Implant Direct, REF654311U, simply InterActive Implant, Surf

Recalled 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


Hazard / Issue

packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.

Issued by

FDA

Affected States: CA, UT, VA, NY, IL, AR, TX, OH, NV, FL, ID, AK, NC, KS, MN, AZ, CO
Lot/Code Info: Lot numbers 120197; Exp. 07/16/2023 and 120198; Exp. 07/19/2023
View official government recall

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