Implant Direct recall
Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,
Why was Implant Direct recalled?
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.
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 # 68209
- 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,
- Recalling firm
- Implant Direct Sybron Manufacturing LLC
- Quantity
- 78 implants
- Distribution
- US: AR, AZ, CA, ID, IL, IN, KY, MD, ND, NH, NJ, NV, NY, Oh, OR, PA, TX, UT, WA, WI, WV, GA,MO
- Recall date
- February 19, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)