Reported Dec 27, 2017 · Terminated
Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit…
Implant Direct Sybron Manufacturing, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Implant Direct Sybron Manufacturing, LLC · 3050 E Hillcrest Dr · Westlake Village, CA · 91362-3171
Is this the product you have?
- Spectra System/Legacy
- Guided Surgery Handle Kit (Part NumberG-HK) Spectra System/Legacy
- Guided Surgery Handle Kit (Part NumberG-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
- Lot codes and dates
Lot # 3866538825425624264943810450144695050165450185016552360529876037662435642456704473431737297477270293
- Amount recalled
- 560 units (worldwide)
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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