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Unrated Medical device recall · FDA · Published May 17, 2024

Fathom C/C Blade Recall: Risk of Bone Fracture from Manufacturing Defect

SEASPINE ORTHOPEDICS CORPORATION recalls Fathom C/C Blades (model MR2102050) due to potential bone fractures from manufacturing defects. Affected units were sold with lot number WT36299C.

🇺🇸 FDA recall #Z-2235-2024Medical deviceFathom ›
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Recalling firmSEASPINE ORTHOPEDICS CORPORATION5770 Armada Dr · Carlsbad, CA 92008-4608
✎ GovInfoNow plain-language explainer

What happened, in plain English

SEASPINE ORTHOPEDICS CORPORATION is recalling Fathom C/C Blades (model MR2102050) because they could cause bone fractures or damage to the bone structure due to manufacturing defects. This recall affects medical devices used in surgical procedures. Read more at govinfonow.com/recall/55045-fathom-c-c-blade-recall-risk-of-bone-fracture-from.

Source Summary by GovInfoNow · govinfonow.com/recall/55045-fathom-c-c-blade-recall-risk-of-bone-fracture-from · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2235-2024

Cite this page

“Fathom C/C Blade Recall: Risk of Bone Fracture from Manufacturing Defect.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55045-fathom-c-c-blade-recall-risk-of-bone-fracture-from. Based on FDA recall #Z-2235-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2235-2024%22&limit=1).

Why it’s dangerous

The blades were manufactured incorrectly, which could lead to fractures or damage to the bone structure during surgical procedures. This defect may occur even when the blades are used as intended.

Who’s affected

Surgical professionals and medical facilities that use the Fathom C/C Blades (model MR2102050) are likely affected. Patients undergoing surgery with these blades face the highest risk of bone injury.

How to tell if you have this one

Check for the model number MR2102050 on the blade or its packaging. Affected units were sold with lot number WT36299C and are used in surgical procedures.

  • Brand
    Fathom
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    United States Nationwide distribution in the states of Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota.
Recall numberProduct, codes & lotsQuantity
Z-2234-2024Brand 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; UDI: 10889981300050 Lot Number: WT36298C21 units
Z-2235-2024Brand 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; UDI: 10889981300067 Lot Number: WT36299C31 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the model number MR2102050 and lot number WT36299C on the blade or its packaging.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 9 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: nationwideILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: nationwideMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “United States Nationwide distribution in the states of Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Michigan, Minnesota, Nevada, New York, Oklahoma, Oregon, Rhode Island, Texas.

Recall timeline

FDA published this recall 54 days after the firm started it.

1. Firm started the recall: May 17, 202412. FDA classified it Class II: Jun 28, 202423. Published in FDA’s Enforcement Report: Jul 10, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2235-2024 (May 17, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2235-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA