Spectra-System Guided Surgery Handle Kit Recall: Small Drill Guide Inserts May Not Fit
Spectra-System recalls Legacy Guided Surgery Handle Kit (Device Listing D245883) due to small drill guide inserts potentially not fitting drills correctly. Affected units include Lot 65249, Sequence Number HE G-HKRev01.
Lower-risk recall
The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.
Contact the company
What happened, in plain English
Spectra-System is recalling its Legacy Guided Surgery Handle Kit because the small drill guide inserts may have a diameter smaller than required. This could cause improper drill fitting during surgery, potentially leading to inaccurate implant placement. Read more at govinfonow.com/recall/73566-spectra-system-guided-surgery-handle-kit-recall-small-drill-guide.
Source Summary by GovInfoNow · govinfonow.com/recall/73566-spectra-system-guided-surgery-handle-kit-recall-small-drill-guide · Updated September 21, 2026 · FDA enforcement record: FDA #Z-3115-2017
Cite this page
“Spectra-System Guided Surgery Handle Kit Recall: Small Drill Guide Inserts May Not Fit.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73566-spectra-system-guided-surgery-handle-kit-recall-small-drill-guide. Based on FDA recall #Z-3115-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3115-2017%22&limit=1).
Why it’s dangerous
The drill guide inserts in the handle kit have a smaller diameter than specified. This could cause the drill to not fit properly when used in surgery, potentially leading to inaccurate implant placement. However, the hazard is not described as causing serious injury in normal use.
Who’s affected
Surgical professionals using the Spectra-System Legacy Guided Surgery Handle Kit (Lot 65249, Sequence Number HE G-HKRev01) are most at risk. The recall affects dental or orthopedic procedures requiring precise implant placement.
How to tell if you have this one
Check for the product name 'Legacy Guided Surgery Handle Kit' with Device Listing Number D245883. Affected units include Lot 65249 and Sequence Number HE G-HKRev01.
- Brand
Spectra-System- Category
Medical device
What to do — step by step
Check Product Details
Verify the device listing number D245883 and lot number 65249 with sequence number HE G-HKRev01.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 27 states.
FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Kansas, Michigan, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington.
Recall timeline
FDA terminated this recall 4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of serious injury?
The recall does not describe a risk of serious injury in normal use, so the danger level is low risk.
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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-3115-2017 (June 26, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3115-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 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.