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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91183

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

Open FDA event record

Event summary

Timeline bucket
November 08, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Corin Ltd

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

Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215

Z-0726-2023
Recall number
Z-0726-2023
Initiated
November 08, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Corin Ltd
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.

Code information

UDI/DI (01) 0 5055196 96833 2, Lot 503150

Distribution pattern

US Nationwide distribution in the states of FL, GA, MA, MI, Ok, PA, TX.

device · product 2 of 2

Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615

Z-0727-2023
Recall number
Z-0727-2023
Initiated
November 08, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Corin Ltd
Quantity
12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.

Code information

UDI/DI (01) 0 5055196 96834, Lot 503151

Distribution pattern

US Nationwide distribution in the states of FL, GA, MA, MI, Ok, PA, TX.