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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94745

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

Open FDA event record

Event summary

Timeline bucket
May 17, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
SEASPINE ORTHOPEDICS CORPORATION

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

Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade

Z-2234-2024
Recall number
Z-2234-2024
Initiated
May 17, 2024
Classification
Class II
Status
Ongoing
Quantity
21 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure

Code information

UDI: 10889981300050 Lot Number: WT36298C

Distribution pattern

United States Nationwide distribution in the states of Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota.

device · product 2 of 2

Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade

Z-2235-2024
Recall number
Z-2235-2024
Initiated
May 17, 2024
Classification
Class II
Status
Ongoing
Quantity
31 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure

Code information

UDI: 10889981300067 Lot Number: WT36299C

Distribution pattern

United States Nationwide distribution in the states of Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota.