Lower risk Medical device recall · FDA · Published November 15, 2017

Implant Direct Spectra System Handle Kit Recall: Guide Inserts Too Small for Drills

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0283-2018Medical device Implant Direct ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmImplant Direct Sybron Manufacturing, LLC3050 E Hillcrest Dr · Westlake Village, CA 91362-3171

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/72535-implant-direct-spectra-system-handle-kit-recall-guide-inserts-too.

Source Summary by GovInfoNow · govinfonow.com/recall/72535-implant-direct-spectra-system-handle-kit-recall-guide-inserts-too · Updated September 1, 2026 · FDA enforcement record: FDA #Z-0283-2018

Cite this page

“Implant Direct Spectra System Handle Kit Recall: Guide Inserts Too Small for Drills.” GovInfoNow, updated September 1, 2026. https://govinfonow.com/recall/72535-implant-direct-spectra-system-handle-kit-recall-guide-inserts-too. Based on FDA recall #Z-0283-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0283-2018%22&limit=1).

Implant Direct Sybron Manufacturing LLC recalled the Spectra System/Leged Guided Surgery Handle Kit (Part Number: G-HK) due to out-of-specification guide inserts, according to the FDA. The agency announced the recall on November 15, 2017.

How to tell if you have it

Brand: Implant Direct
Product: Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK)
Lot codes: 38665, 38825, 42562, 42649, 43810, 45014, 46950, 50165, 45018, 50165, 52360, 52987, 60376, 62435, 64245, 67044, 73431, 73729, 74772, 70293
Units affected: 560

The hazard

The guided handle inserts were out of Implant Direct specifications. Clinicians reported that the 3.4mm guide insert was too small to allow the 3.4 drill to pass through, while the 2.3mm guide was too large.

Context

GovInfoNow's records show Implant Direct Sybron Manufacturing LLC has 20 other recalls on record since June 26, 2017. Other recent recalls of similar products include Sybron Drill Stop Kit Recall (May 1, 2025), Sybron Legacy Smartbase Recalls (May 2, 2023), and ImplantDirect Legacy 2 dental implants recall (September 23, 2021). Other recent recalls of similar products include Medicrea IB3D Universal Implant Inserter Recall (October 29, 2025), Medicrea IB3D PL Instruments Set Recall (October 29, 2025), and Merit Medical Custom Procedure Kit Recall (December 4, 2025).

How to tell if you have this one

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.

Brand
Implant Direct
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Numbers
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.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Europe, Canada, Australia, Egypt, Jordan, and Lebanon.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

Nov 15, 2017Firm started the recall
Dec 21, 2017FDA classified it Class II
Dec 27, 2017Published in FDA’s Enforcement Report
Oct 9, 2018FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/72535-implant-direct-spectra-system-handle-kit-recall-guide-inserts-too">Implant Direct Spectra System Handle Kit Recall: Guide Inserts Too Small for Drills (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-0283-2018 (November 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0283-2018 to see it in context.
Plain-language summary written by qwen3:4b on September 1, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.