Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,
Reported: February 19, 2020 Initiated: October 11, 2019 #Z-1157-2020
Product Description
Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,
Reason for Recall
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.
Details
- Recalling Firm
- Implant Direct Sybron Manufacturing LLC
- Units Affected
- 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
- Location
- Westlake Village, CA
Frequently Asked Questions
What product was recalled? ▼
Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,. Recalled by Implant Direct Sybron Manufacturing LLC. Units affected: 78 implants.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 19, 2020. Severity: Moderate. Recall number: Z-1157-2020.
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