Exact FDA event identifier

Event 73579

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

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Event summary

Timeline bucket: January 11, 2016
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Arthrex, 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

Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.

Z-1360-2016

Recall number: Z-1360-2016
Initiated: January 11, 2016
Classification: Class II
Status: Terminated
Recalling firm: Arthrex, Inc.
Quantity: 117 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for a component contained in the Implant System to be non-sterile.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

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Reason for recall

Potential for a component contained in the Implant System to be non-sterile.

Code information

Unique Device Identifier: 00888867131446; Catalog No.: AR-8918CP; Batch No.: 10020303.

Distribution pattern

Distributed to the states of AR, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MD, MO, NC, NJ, NV, NY, OH, PA, SD, TN, TX, and WI.