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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90484

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

Open FDA event record

Event summary

Timeline bucket
November 12, 2019
Product types
Device
Classifications
Class II
Statuses
Completed
Recalling firm wording
Aesculap Implant Systems LLC

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

ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.

Z-1391-2022
Recall number
Z-1391-2022
Initiated
November 12, 2019
Classification
Class II
Status
Completed
Quantity
67

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.

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

Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.

Code information

UDI-DI (GTIN): 04046963419639

Distribution pattern

US Nationwide distribution in the states of AL, AZ, CA, CO, ID, IL, LA, MA, MO, NC, OK, TX, WI.