Implant Direct Sybron Manufacturing, LLC recalls Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows c

Recalled September 20, 2017 · FDA recall Z-3115-2017 · Implant Direct Sybron Manufacturing

Hazard

The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require. · FDA Class II

Units

84 units

Sold at

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.

Description

The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.

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.

Manufacturer(s)

Implant Direct Sybron Manufacturing, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →