Z-0089-2019 Class II Terminated
FDA device recall Z-0089-2019 was initiated by Implant Direct Sybron Manufacturing, LLC on May 29, 2018 and is designated Class II. Reason for recall: Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label. The recall status is terminated (terminated July 29, 2020). Affected quantity: 217 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 17, 2018
- Initiation Date
- May 29, 2018
- Termination Date
- July 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 217 units
Product Description
Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.
Reason for Recall
Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.
Distribution Pattern
Worldwide distribution. US nationwide, Canada, Germany, Great Britain, Kuwait, Lithuania, Monaco, Netherlands, and Slovakia.
Code Information
Part number 8735-05, Lot number 90212