Implant Direct recalls Spectra System/Legacy Guided Surgery Handle Kits with faulty guide inserts that may prevent 3.4mm drills from passing through. Affected kits have specific lot numbers.
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.
Implant Direct is recalling Spectra System/Legacy Guided Surgery Handle Kits because the guide inserts are too small or too large for standard surgical drills, which could lead to improper implant placement during surgery. This recall affects specific lot numbers of the handle kits.
The guide inserts in the handle kit are either too small (3.4mm) or too large (2.3mm) compared to standard surgical drill sizes. This mismatch could prevent the drill from passing through the guide, potentially causing improper implant placement during surgery.
Surgical professionals who own or use the Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) with the listed lot numbers are most at risk. The recall targets specific batches sold to clinics and hospitals.
Check the lot numbers on the handle kit: 38665, 38825, 42562, 42649, 43810, 45014, 46950, 50165, 52360, 52987, 60376, 62435, 64245, 67044, 73431, 73729, 74772, 70293. The handle kit is used by clinicians for precise surgical implant placement.
Look for the specific lot numbers listed in the recall: 38665, 38825, 42562, 42649, 43810, 45014, 46950, 50165, 52360, 52987, 60376, 62435, 64245, 67044, 73431, 73729, 74772, 70293.
The guide inserts in the Spectra System/Legacy Guided Surgery Handle Kit are either too small (3.4mm) or too large (2.3mm) compared to standard surgical drills, which could prevent the drill from passing through the guide.
Check the lot numbers on your handle kit. If it matches the listed numbers, contact Implant Direct for further instructions.
The handle kit may cause improper implant placement during surgery if the guide insert does not allow the drill to pass through, but the recall is for specific lot numbers.
We’ve drafted a message you can send Implant Direct to request your refund or repair — edit it as you like.
Subject: Recall Z-0283-2018 — Implant Direct Implant Direct Hello, I own a Implant Direct that is covered by recall Z-0283-2018 from Implant Direct. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
