Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64160

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

Open FDA event record

Event summary

Timeline bucket
December 17, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medacta Usa 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

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

Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery.

Z-0791-2013
Recall number
Z-0791-2013
Initiated
December 17, 2012
Classification
Class II
Status
Terminated
Recalling firm
Medacta Usa Inc
Quantity
26 pieces U.S.A. (226 pieces Worldwide)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The tip of the Quadra Trial Broach size 0, broke during a surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The tip of the Quadra Trial Broach size 0, broke during a surgery.

Code information

Lot/Unit Codes: 075023, 075064, 084000, 084001, 084326, 084743, 084815, 085202, 085455

Distribution pattern

US Nationwide Distribution including the states of Arizona, California, Idaho, Illinois, North Carolina, Ohio, Utah, Washington and US Virgin Islands