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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89522

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 13, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
K2M, 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

2 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 2

Everest MI XT Inner Dilator, Catalog Number 5101-90167

Z-0705-2022
Recall number
Z-0705-2022
Initiated
January 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
K2M, Inc
Quantity
686 Total Devices

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing nonconformance

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.

Code information

GTIN: 10888857261204; Lot Numbers: JUJF KFMV KUPG KYYU MDRB NDMK NDMX NXJK

Distribution pattern

Worldwide distribution - US Nationwide.

device · product 2 of 2

Everest MI XT Outer Dilator, Catalog Number 5101-90168

Z-0706-2022
Recall number
Z-0706-2022
Initiated
January 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
K2M, Inc
Quantity
686 Total Devices

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing nonconformance

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.

Code information

GTIN: 10888857261211; Lot Numbers: HCBN HCBP JUJJ KFMX KUPH KYYV MDPF NAKJ NDGT PCCN

Distribution pattern

Worldwide distribution - US Nationwide.