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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70551

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

Open FDA event record

Event summary

Timeline bucket
February 11, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Sybron Dental Specialties

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

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

Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number: 4513C or 4513-1 Single Patient Use Fits 13mm Tips. Pack of 400. Metrex Research, Manufacturer. Inner individual packaging of each sleeve: Cure Sleeve by Pinnacle Model 4500

Z-1291-2015
Recall number
Z-1291-2015
Initiated
February 11, 2015
Classification
Class II
Status
Terminated
Recalling firm
Sybron Dental Specialties
Quantity
172

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. There is a low risk associated with the use of the product as the sleeve may tear causing a potential for cross contamination.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

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Inspect official wording and provenance

Reason for recall

Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. There is a low risk associated with the use of the product as the sleeve may tear causing a potential for cross contamination.

Code information

Part Number: 4513C or 4513-1. Lot Number: 2014030110

Distribution pattern

Worldwide distribution. US Nationwide, Canada, Australia, Netherlands, Switzerland, Japan,