CLASS II ONGOING Device recall · Reported 10 Jul 2024 · FDA Enforcement Report

Fathom Pedicle-Based Retractor C/C Blade recalled

Seaspine Orthopedics is recalling Fathom Pedicle-Based Retractor C/C Blade, 35, distributed nationwide in the US. The recall was initiated on 17 May 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 10889981300050 Lot Number: WT36298C

Quantity recalled21 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2234-2024
FDA event ID: 94745
Recalling firm: Seaspine Orthopedics, Carlsbad, CA
Classification: Class II
Status: Ongoing
Recall initiated: 17 May 2024
FDA classified: 28 Jun 2024
Reported: 10 Jul 2024
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

17 May 2024	Recall initiated by company
28 Jun 2024	Classified by FDA	+42 days
10 Jul 2024	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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

Nationwide California Michigan Minnesota Nevada New York Oklahoma Oregon Rhode Island Texas

Questions about this recall

Why was it recalled?

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

Which lots are affected?

UDI: 10889981300050 Lot Number: WT36298C

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 94745

This product is part of a recall event; the main page for the event is Fathom Pedicle-Based Retractor C/C Blade recalled.

Reported	Class	Recall	Company	Reason	Where
10 Jul 2024	CLASS II	Fathom Pedicle-Based Retractor C/C Blade recalled	Seaspine Orthopedics	Other	Nationwide

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