Device product
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.
Z-3115-2017
Product summary
- Event
- Event 77554
- Status
- Terminated
- Classification
- Class II
- Quantity
- 84 units
- Official record key
device-enforcement:Z-3115-2017
Official wording
Reason: The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.
Code information: Lot 65249, Sequence Number HE G-HKRev01, Device Listing Number D245883.
Distribution pattern: 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.
Derived failure modes
-
Unknown
The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.