Z-1157-2020 Class II Terminated
FDA device recall Z-1157-2020 was initiated by Implant Direct Sybron Manufacturing LLC on October 11, 2019 and is designated Class II. 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 … The recall status is terminated (terminated April 12, 2024). Affected quantity: 78 implants.
Recall Details
- Product Type
- Devices
- Report Date
- February 19, 2020
- Initiation Date
- October 11, 2019
- Termination Date
- April 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 78 implants
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.
Distribution Pattern
US: AR, AZ, CA, ID, IL, IN, KY, MD, ND, NH, NJ, NV, NY, Oh, OR, PA, TX, UT, WA, WI, WV, GA,MO
Code Information
Lot # 68209