Exact FDA event identifier

Event 77467

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

Open FDA event record

Event summary

Timeline bucket: May 19, 2017
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 GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO

Z-2661-2017

Recall number: Z-2661-2017
Initiated: May 19, 2017
Classification: Class II
Status: Terminated
Recalling firm: Medacta Usa Inc
Quantity: 4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

One lot of product does not include a screw for attachment to the tibial base plate.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

One lot of product does not include a screw for attachment to the tibial base plate.

Code information

Lot # 163646

Distribution pattern

CA, AZ, NC, Israel, France