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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87565

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

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Event summary

Timeline bucket
March 16, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
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

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

Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033

Z-1410-2021
Recall number
Z-1410-2021
Initiated
March 16, 2021
Classification
Class II
Status
Terminated
Recalling firm
K2M, Inc
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with the inserters. As a result, inner shafts do not mate flush with the collet inserters, and splaying of the collet. If implant falls into the spinal cord may cause a spinal cord injury or Incomplete seating of the inserter to the implant could result in misalignment of the screws with the inserter screw guide, potentially causing malposition of the screws into the adjacent vertebral bodies

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

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Inspect official wording and provenance

Reason for recall

Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with the inserters. As a result, inner shafts do not mate flush with the collet inserters, and splaying of the collet. If implant falls into the spinal cord may cause a spinal cord injury or Incomplete seating of the inserter to the implant could result in misalignment of the screws with the inserter screw guide, potentially causing malposition of the screws into the adjacent vertebral bodies

Code information

Lot Number: MNAJ GTIN: 10888857082571

Distribution pattern

PA