Z-1823-2017 Class II Terminated
FDA device recall Z-1823-2017 was initiated by Zimmer Dental Inc on March 20, 2017 and is designated Class II. Reason for recall: It was manufactured with the minor diameter of the internal thread that is below specification. The recall status is terminated (terminated November 1, 2017). Affected quantity: 188 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 26, 2017
- Initiation Date
- March 20, 2017
- Termination Date
- November 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 188 units
Product Description
Tapered SwissPlus Implant System, Model No. SPB10
Reason for Recall
It was manufactured with the minor diameter of the internal thread that is below specification.
Distribution Pattern
Worldwide: ZA, FR, IT, IR
Code Information
Lot #63498673; UDI: (01) 008890240177 (10) 63498673 (17) 200731