Exact FDA event identifier

Event 91613

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

Open FDA event record

Event summary

Timeline bucket: January 25, 2023
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Limacorporate S.p.A

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

TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)

Z-1261-2023

Recall number: Z-1261-2023
Initiated: January 25, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Limacorporate S.p.A
Quantity: 5 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.

Code information

Product Code: 1590.15.010 UDI-DI Code: 08033390128865 Lot Number: 2115522 Sterilization Lot Number: 2100241

Distribution pattern

U.S. Distribution to: TX