Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (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 consist 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
- June 26, 2017
- Terminated
- June 16, 2021
- Recall Number
- Z-3115-2017
- Quantity
- 84 units
- Firm Location
- Westlake Village, CA
Reason for Recall
The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.
Distribution
Worldwide Distribution - USA (nationwide) Distribution to the states of : AZ, CA, CO, CT, FL, ID, IL, KS, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA., and to the countries of : Canada, Netherlands, Spain, Great Britain, Germany and Switzerland.
Lot / Code Info
Lot 65249, Sequence Number HE G-HKRev01, Device Listing Number D245883.
Root Cause
Process control
Action Taken
Implant Direct sent an Safety Alert /Advisory Notice letter dated June 26, 2017. Instructions included to review and remove inventory for return to Implant Direct, complete and return the acknowledgement and recall return form, and contact customers and notify the of the recall if product was further distributed. For further questions, please call (888) 649-6425.