Exact FDA event identifier

Event 80763

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

Open FDA event record

Event summary

Timeline bucket: May 08, 2018
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

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

Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.

Z-3209-2018

Recall number: Z-3209-2018
Initiated: May 08, 2018
Classification: Class II
Status: Ongoing
Recalling firm: Exactech, Inc.
Quantity: 1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potentially have non-conforming internal threads.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially have non-conforming internal threads.

Code information

Catalog #: 02-012-60-2216 Serial Number: 5370045

Distribution pattern

US Distribution to Ohio only.