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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82374

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

Open FDA event record

Event summary

Timeline bucket
February 22, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Keystone Dental Inc

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

4 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 4

Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 60-70112

Z-1061-2019
Recall number
Z-1061-2019
Initiated
February 22, 2019
Classification
Class II
Status
Terminated
Recalling firm
Keystone Dental Inc
Quantity
13 kits hex Driver

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature

Code information

Lot Numbers: WO-010252, WO-010136

Distribution pattern

FL, MA, SC, VA

device · product 2 of 4

Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 30-70021

Z-1062-2019
Recall number
Z-1062-2019
Initiated
February 22, 2019
Classification
Class II
Status
Terminated
Recalling firm
Keystone Dental Inc
Quantity
1 hex Driver

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature

Code information

Lot Numbers: WO-010366

Distribution pattern

FL, MA, SC, VA

device · product 3 of 4

Paltop 1.25 Hex Drivers, Long Part Number: 60-70101

Z-1063-2019
Recall number
Z-1063-2019
Initiated
February 22, 2019
Classification
Class II
Status
Terminated
Recalling firm
Keystone Dental Inc
Quantity
3 hex Driver

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature

Code information

Lot Number: WO-010352

Distribution pattern

FL, MA, SC, VA

device · product 4 of 4

Paltop 1.25 Hex Drivers, Short Part Number: 60-70102

Z-1064-2019
Recall number
Z-1064-2019
Initiated
February 22, 2019
Classification
Class II
Status
Terminated
Recalling firm
Keystone Dental Inc
Quantity
3 Hex Driver

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature

Code information

Lot Number: WO-010354

Distribution pattern

FL, MA, SC, VA