Exact FDA event identifier

Event 68093

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

Open FDA event record

Event summary

Timeline bucket: March 19, 2014
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Biorep Technologies

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

Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for retraction of the atrial wall tissue in cardiac surgery.

Z-1538-2014

Recall number: Z-1538-2014
Initiated: March 19, 2014
Classification: Class II
Status: Terminated
Recalling firm: Biorep Technologies
Quantity: 80 boxes (480 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.

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

The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.

Code information

Lot numbers: 166934413 (expires 2016/12/10), and 166903414 (expires 2017/02/03).

Distribution pattern

US Distribution to a distributor in MN.