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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90753

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

Open FDA event record

Event summary

Timeline bucket
July 13, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Paragon 28, 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

Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System

Z-1776-2022
Recall number
Z-1776-2022
Initiated
July 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Paragon 28, Inc.
Quantity
145

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.

Code information

UDI-DI: 00889795114228, Lot: 5007499

Distribution pattern

US Nationwide distribution in the states of AZ, IN, LA, NJ, TX, WA, NY, MD, WI, OK, KY, MI, OH, CA, FL, KS, PA.