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Terminated

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

FDA Recall Z-0351-2018 · Posted None

Recalling FirmHologic, Inc.
Recall StatusTerminated
Product CodeOIJ
Date Initiated2017-07-07
Date Terminated2018-04-04
Product Quantity12 (U.S.)

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.

Firm Action

Letter

Root Cause

Component change control

Distribution Pattern

US and OUS

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K161575Affirm Lateral Arm Upright Biopsy AccessoryHologic · 2016-08-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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