Recall Z-0283-2018 ยท NDP Accessories, Implant, Dental, Endosseous
Implant Direct Sybron Manufacturing, LLC
Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consists of 4 guide handles with inserts attached on each end. Each insert has
| Date | Nov 15, 2017 |
| Status | Terminated |
| Reason | The Spectra System/Legacy Guided Surgery Handle Kit had guided handle inserts that were out of Implant Direct specifications, from the results of complaints submitted by clinicians regarding the 3.4mm guide insert that will not allow the 3.4 drill to pass through, since the diameter is too small. In addition, the 2.3mm guide was too large. |
| Root cause | Labeling mix-ups |
| Action | On November 22, 2017, the recalling firm will send consignees customer letters with replacement product, requesting nonconforming product to be returned to Implant Direct with return labels and packaging. The recalling firm will then initiate calls 24 hours after the communication is sent to the clinician; initiate second calls 72 hours after the communication is sent; and initiate third calls 5 working days after the communication is sent. For further questions, please call (818) 444-3300. |
| Quantity | 560 units (worldwide) |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Europe, Canada, Australia, Egypt, Jordan, and Lebanon. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.