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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88859

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 23, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
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.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 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 2

ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,

Z-0197-2022
Recall number
Z-0197-2022
Initiated
September 23, 2021
Classification
Class II
Status
Ongoing
Quantity
61 implants

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Packaged dental implant contains a different size then the size declared on the labeling.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packaged dental implant contains a different size then the size declared on the labeling.

Code information

lot # 166297 / UDI: 10841307101789

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, HI, IL, KS, LA, MA, MD, MI, MO, MT, NE, NJ, NY, OH, OR, PA, RI, SC, TX, UT, VA, WA, WI and the country of Japan.

device · product 2 of 2

ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,

Z-0198-2022
Recall number
Z-0198-2022
Initiated
September 23, 2021
Classification
Class II
Status
Ongoing
Quantity
83 implants

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Packaged dental implant contains a different size then the size declared on the labeling.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packaged dental implant contains a different size then the size declared on the labeling.

Code information

lot # 166300 / UDI: 10841307101796

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, HI, IL, KS, LA, MA, MD, MI, MO, MT, NE, NJ, NY, OH, OR, PA, RI, SC, TX, UT, VA, WA, WI and the country of Japan.