Exact FDA event identifier

Event 66355

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

Open FDA event record

Event summary

Timeline bucket: August 23, 2013
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Medtronic Xomed, 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

Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.

Z-2284-2013

Recall number: Z-2284-2013
Initiated: August 23, 2013
Classification: Class II
Status: Terminated
Recalling firm: Medtronic Xomed, Inc.
Quantity: 60

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.

Code information

REF: 1150000 Lot: 0207029284

Distribution pattern

Nationwide Distribution (US), including the states of CA, NE, GA, and IL.