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Recall Observatory FDA recall evidence

Device 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.

Z-0283-2018

November 15, 2017

Class II

Product summary

Firm
Implant Direct Sybron Manufacturing, LLC
Event
Event 78583
Status
Terminated
Classification
Class II
Quantity
560 units (worldwide)
Official record key
device-enforcement:Z-0283-2018

Official wording

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.

Code information: Lot # 38665, 38825, 42562, 42649, 43810, 45014, 46950, 50165, 45018, 50165, 52360, 52987, 60376, 62435, 64245, 67044, 73431, 73729, 74772, 70293

Distribution pattern: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Europe, Canada, Australia, Egypt, Jordan, and Lebanon.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.