Exact FDA event identifier

Event 95653

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

Open FDA event record

Event summary

Timeline bucket: October 30, 2024
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: INCIPIO DEVICES

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

Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.

Z-0549-2025

Recall number: Z-0549-2025
Initiated: October 30, 2024
Classification: Class II
Status: Ongoing
Recalling firm: INCIPIO DEVICES
Quantity: 100 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

does not meet specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.

Code information

Product Reference No.: 50341105; UDI-DI: 07630055304735; Lot No.: 24A0087.

Distribution pattern

US Nationwide distribution in the state of TN.