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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89014

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

Open FDA event record

Event summary

Timeline bucket
November 09, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ossur Americas

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

Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use

Z-0380-2022
Recall number
Z-0380-2022
Initiated
November 09, 2021
Classification
Class II
Status
Terminated
Recalling firm
Ossur Americas
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.

Code information

Instructions for Use Rev. 3 2018

Distribution pattern

US Nationwide distribution in the states of CA, NH, CT, RI, MA, FL, DE, NY, NJ, PA, OH, DC, MD, VA, NC, SC, GA, MS, LA, TN, TX, KY, IN, AZ, MI, WI, MN, IL, IA, MO, NE, MT, ID, CO, NM, WA, OR, NV, UT, KS, AK, VT, AR, OK, AL, SD, WV, PR.