Z-0185-2018 Class II Terminated
FDA device recall Z-0185-2018 was initiated by Implant Direct Sybron Manufacturing, LLC on October 10, 2017 and is designated Class II. Reason for recall: One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. … The recall status is terminated (terminated September 27, 2018). Affected quantity: 75 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 6, 2017
- Initiation Date
- October 10, 2017
- Termination Date
- September 27, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 75 units
Product Description
ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Reason for Recall
One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. As a result, the cap could possibly not be screwed on properly and the sterilization compromised.
Distribution Pattern
Worldwide distribution: US (nationwide) including Puerto Rico and country of Japan.
Code Information
Lot Number: 79607