Implant Direct Sybron Manufacturing, LLC: Medical Device Recall in 2017 - (Recall #: Z-3115-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 26, 2017

Date Posted: September 20, 2017

Recall Number: Z-3115-2017

Event ID: 77554

Reason for Recall:

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

Status: Terminated

Product Quantity: 84 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated