Recall events
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Event 86694
Event summary
Timeline bucket October 20, 2020
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording Coltene Whaledent 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
5 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 5
Alpen Clinic 100 Carbide Instruments (R100057C)
Z-0464-2021
Recall number Z-0464-2021
Initiated October 20, 2020
Classification Class II
Status Ongoing
Quantity 556 packs
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0464-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[28359]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Distribution pattern Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[32161]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 5
FG 57 100057X (100057X)
Z-0465-2021
Recall number Z-0465-2021
Initiated October 20, 2020
Classification Class II
Status Ongoing
Quantity 556
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0465-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[40005]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Distribution pattern Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[31710]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 5
Clinic Pack 100 Pieces FG 57 100057C (100057C)
Z-0466-2021
Recall number Z-0466-2021
Initiated October 20, 2020
Classification Class II
Status Ongoing
Quantity 556
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0466-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33390]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Distribution pattern Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[32195]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 5
CEI Cutting Edge Instruments (PTC-57C)
Z-0467-2021
Recall number Z-0467-2021
Initiated October 20, 2020
Classification Class II
Status Ongoing
Quantity 556
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0467-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[50663]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Distribution pattern Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[32158]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 5
Strauss 25 Carbide Dental Burs (100057XXV)
Z-0468-2021
Recall number Z-0468-2021
Initiated October 20, 2020
Classification Class II
Status Ongoing
Quantity 556
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0468-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33392]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Code information J77147 J93636
Distribution pattern Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[32174]
FDA event record
· Exact recall-number query on openFDA
