Recall Z-0283-2018— Implant Direct Sybron Manufacturing, LLC

Class II FDA medical device recall by Implant Direct Sybron Manufacturing, LLC, initiated 2017-11-15, terminated 2018-10-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: 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 consists 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: The Spectra System/Legacy Guided Surgery Handle Kit had guided handle inserts that were out of Implant Direct specifications, from the results of complaints submitted by clinicians regarding the 3.4mm guide insert that will not allow the 3.4 drill to pass through, since the diameter is too small. In addition, the 2.3mm guide was too large..

Recalling firm

Implant Direct Sybron Manufacturing, LLC

Classification

Class II

Status

Terminated

Initiated

2017-11-15

Terminated

2018-10-09

Firm location

Westlake Village, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.