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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78777

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

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Event summary

Timeline bucket
July 07, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Hologic, 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

Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880

Z-0351-2018
Recall number
Z-0351-2018
Initiated
July 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Hologic, Inc.
Quantity
12 (U.S.)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm is implementing a product correction involving its Affirm¿ Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the Blue Needle Guide) issue that could impact needle alignment for all the left-approach lateral biopsy procedures. This may have an impact on the position of the needle within the breast, and thus on the aspiration of the intended tissue. This impact is case-dependent and detectable when imagining is used to confirm needle position and/or tissue acquisition during and after a procedure. There are no known instances of illness or injury.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm is implementing a product correction involving its Affirm¿ Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the Blue Needle Guide) issue that could impact needle alignment for all the left-approach lateral biopsy procedures. This may have an impact on the position of the needle within the breast, and thus on the aspiration of the intended tissue. This impact is case-dependent and detectable when imagining is used to confirm needle position and/or tissue acquisition during and after a procedure. There are no known instances of illness or injury.

Code information

UDI Number: 15420045506817 Serial Numbers: LAT1200100 LAT1200165

Distribution pattern

US and OUS

Field note

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