Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
Recall
- Recall Number
- Z-2125-2017
- Event Number
- 77171
- Firm
- Implant Direct Sybron Manufacturing, LLC
- FEI Number
- 3001617766
- Product Code
- DZE
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- May 2, 2017
- Terminated
- January 8, 2018
- Address
- 3050 E Hillcrest Dr, Westlake Village, CA, 91362-3171
Description
Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification.
Implant Direct sent an Urgent Medical Device Field Corrective recall letter dated April 2017 to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are informed that the product may be out of Implant Direct specification. The abutment should have a full hex configuration from end of part to shoulder (1.6mm). When the part is in-correct there will be a noticeable diameter ring just above shoulder and a hex flat face that appears short (@ 1.1mm) not allowing full engagement to implant analog. This discrepancy may lead to the possibility of the abutment not seating properly on the implant, and if undetected may lead to micro-leakage and a possible infection to the patient. Customers are instructed to complete and return the Acknowledgement and Recall Return form within 48 hrs. Customers with any questions are instructed to contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425.
Worldwide Distribution - Nationwide Distribution and to the countries of : European Union (HU, GB, DE, DK, IT, HR, FR), and Japan
151 units