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 an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.
- Recall Initiated
- November 15, 2017
- Terminated
- October 9, 2018
- Recall Number
- Z-0283-2018
- Quantity
- 560 units (worldwide)
- Firm Location
- Westlake Village, CA
Reason for Recall
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.
Distribution
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Europe, Canada, Australia, Egypt, Jordan, and Lebanon.
Lot / Code Info
Lot # 38665, 38825, 42562, 42649, 43810, 45014, 46950, 50165, 45018, 50165, 52360, 52987, 60376, 62435, 64245, 67044, 73431, 73729, 74772, 70293
Root Cause
Labeling mix-ups
Action Taken
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.