FDAFDA · Food and drugs·Recall number Z-3115-2017
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.
Published September 20, 2017 · Recall initiated: June 26, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Distributor
- 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.
- Lot
- Lot 65249, Sequence Number HE G-HKRev01, Device Listing Number D245883.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.