medical Class II Updated 2020-02-19

Implant Direct Sybron Manufacturing LLC recalls Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surfa

Recalled Product

Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,


Hazard / Issue

Through a customer complaint and and internal investigation it was determined that some implant packages contain the incorrect cover screw and extender. This could result in delay in surgery and/or a potential new surgical procedures to place the correct parts. The level of severity varies based on a one or two stage surgery.

Issued by

FDA

Affected States: AR, AZ, CA, ID, IL, IN, KY, MD, ND, NH, NJ, NV, NY, OR, PA, TX, UT, WA, WI, WV, GA, MO
Lot/Code Info: Lot # 68209
View official government recall

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