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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77554

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
June 26, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Implant Direct Sybron Manufacturing, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-3115-2017
Recall number
Z-3115-2017
Initiated
June 26, 2017
Classification
Class II
Status
Terminated
Quantity
84 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

Reason for recall

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

Code information

Lot 65249, Sequence Number HE G-HKRev01, Device Listing Number D245883.

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.