Z-3115-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 20, 2017
- Initiation Date
- June 26, 2017
- Termination Date
- June 16, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 84 units
Product Description
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.
Reason for Recall
The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.
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.
Code Information
Lot 65249, Sequence Number HE G-HKRev01, Device Listing Number D245883.