PlainRecalls
FDA Devices Moderate Class II Terminated

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 g

Reported: September 20, 2017 Initiated: June 26, 2017 #Z-3115-2017

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.

Details

Units Affected
84 units
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.
Location
Westlake Village, CA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Implant Direct Sybron Manufacturing, LLC. Units affected: 84 units.
Why was this product recalled? ▼
The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 20, 2017. Severity: Moderate. Recall number: Z-3115-2017.

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