Recall Z-1823-2017 ยท DZE Implant, Endosseous, Root-Form
Zimmer Dental Inc
Tapered SwissPlus Implant System, Model No. SPB10
| Date | Mar 20, 2017 |
| Status | Terminated |
| Reason | It was manufactured with the minor diameter of the internal thread that is below specification. |
| Root cause | Nonconforming Material/Component |
| Action | A customer letter was sent on 3/20/17 to inform customers that Zimmer Biomet is recalling a single lot of the Tapered SwissPlus 3.7mmD Implant, Lot No. 63498673. The letter informs customers that the recall is due to one (1) lot of part number SPB10 (lot 63498673) that was manufactured with the minor diameter of the internal thread below specification. This condition may cause mating issues with some screws. The condition occurs when the screw used has a minor thread diameter that is closer to the maximum allowed diameter (maximum material condition). However, screws closer to the least mater |
| Quantity | 188 units |
| Distribution | Worldwide: ZA, FR, IT, IR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082639 | ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS Zimmer Dental, Inc., Dec 19, 2008 |