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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 guide sleeve that is embedded into a surgical guide.

FDA Recall Z-3115-2017 · Posted None

Recalling FirmImplant Direct Sybron Manufacturing, LLC
Recall StatusTerminated
Product CodeLXH
Date Initiated2017-06-26
Date Terminated2021-06-16
Product Quantity84 units

Reason for Recall

The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.

Firm Action

Implant Direct sent an Safety Alert /Advisory Notice letter dated June 26, 2017. Instructions included to review and remove inventory for return to Implant Direct, complete and return the acknowledgement and recall return form, and contact customers and notify the of the recall if product was further distributed. For further questions, please call (888) 649-6425.

Root Cause

Process control

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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