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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92414

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

Open FDA event record

Event summary

Timeline bucket
June 05, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.

Z-2050-2023
Recall number
Z-2050-2023
Initiated
June 05, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
250 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.

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

The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.

Code information

Catalog #531-07-05 - Lot numbers: 154287001, 295878002, and 302331004; UDI-DI 10885862542038.

Distribution pattern

Distribution was made to AR, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, ME, MN, NH, NV, NY, OH, OK, PA, SC, TN, TX, WI, as well as PR. There was no government/military distribution. Foreign distribution was made to Australia, France, and Japan.

device · product 2 of 2

Exactech Ergo Impactor Handle, Catalog #321-09-05.

Z-2051-2023
Recall number
Z-2051-2023
Initiated
June 05, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
784 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.

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

The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.

Code information

Catalog #321-09-05 - Lot numbers: 147544002, 275151004, 275151005, 275151006, 314934001, 400107002, and 400798002; UDI-DI 10885862557674. Updated data - 01/31/2025: Additional Lot Numbers 401819005 401819007 401819008 404552002 405492002 405253003 406041001

Distribution pattern

Distribution was made to AR, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, ME, MN, NH, NV, NY, OH, OK, PA, SC, TN, TX, WI, as well as PR. There was no government/military distribution. Foreign distribution was made to Australia, France, and Japan.