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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86630

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

Open FDA event record

Event summary

Timeline bucket
October 06, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Exactech, 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

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

Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium

Z-0459-2021
Recall number
Z-0459-2021
Initiated
October 06, 2020
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
69 devices

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product may be mislabeled.

Code information

Catalog 314-13-23, Serial Numbers: 6262746 6262747 6262748 6262749 6262750 6262751 6262753 6262754 6262756 6262757 6262758 6262759 6262760 6262761 6262762 6262763 6142776 6142777 6142779 6142780 6142782 6142783 6142785 6142787 6142788 6142790 6142792 6142793 6142794 6142795 6142796 6142798 6142801 6142802 6142803 6142804 6130334 6130335 6130336 6130340 6130341 6130343 6130344 6130347 6130352 6130353 6130355 6130356 6130357 6130358 6130361 6130365 6130366 6130367 6130368 6147287 6147294 6147297 6147298 6147299 6147300 6147301 6147303 6147303 6147308 6147310 6147314 6147317 6147318

Distribution pattern

US consignees - AZ, CA, CO, FL, IL, IN, KY, LA, OH, OK, MD, ME, MN, NV, NY, SC, TN, TX, VA, WA, WI International consignees - Australia, Japan, and United Kingdom

device · product 2 of 2

Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium

Z-0460-2021
Recall number
Z-0460-2021
Initiated
October 06, 2020
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
40 devices

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product may be mislabeled.

Code information

Catalog 314-13-33, Serial Numbers: 6259572 6259573 6259575 6259577 6259578 6259579 6259583 6259584 6259587 6259588 6259590 6259591 6259592 6259594 6259595 6132993 6132994 6132995 6132996 6132997 6132998 6132999 6133000 6133002 6133003 6133005 6133008 6133009 6133010 6133011 6133013 6133014 6133017 6133020 6133021 6133023 6133029 6133030 6133031 6133032

Distribution pattern

US consignees - AZ, CA, CO, FL, IL, IN, KY, LA, OH, OK, MD, ME, MN, NV, NY, SC, TN, TX, VA, WA, WI International consignees - Australia, Japan, and United Kingdom

Field note

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