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Use caution Medical device recall · FDA · Published November 28, 2018

Howmedica Tritanium PL Cage Recall: Risk of Intra-Operative Fractures

Howmedica recalls Tritanium Posterior Lumbar cage implants due to reports of fractures during and after surgery. Affected models include specific lot numbers and model numbers listed in the recall notice.

🇺🇸 FDA recall #Z-0605-2019Medical deviceHowmedica ›
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Recalling firmHowmedica Osteonics Corp.2 Pearl Ct · Allendale, NJ 07401-1611
✎ GovInfoNow plain-language explainer

Howmedica is recalling certain Tritanium Posterior Lumbar (PL) cage implants used in spinal fusion surgery because they have been reported to fracture during or after the procedure. This could lead to complications for patients who have received these implants. Read more at govinfonow.com/recall/69421-howmedica-tritanium-pl-cage-recall-risk-of-intra-operative-fractures.

Source Summary by GovInfoNow · govinfonow.com/recall/69421-howmedica-tritanium-pl-cage-recall-risk-of-intra-operative-fractures · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0605-2019

Cite this page

“Howmedica Tritanium PL Cage Recall: Risk of Intra-Operative Fractures.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69421-howmedica-tritanium-pl-cage-recall-risk-of-intra-operative-fractures. Based on FDA recall #Z-0605-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0605-2019%22&limit=1).

The FDA announced on November 28, 2018, that Howmedica Osteonics Corp. is recalling its Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implants due to reports of cage fractures. The agency issued recall number Z-0605-2019 for the Class II device.

How to tell if you have it

  • Brand: Howmedica
  • Product: Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant
  • Model Numbers: 48950070, 48950076, 48950080, 48950086, 48950090, 48950096, 48950100, 48950106, 48950110, 48950116, 48950120, 48950126, 48950130, 48950136, 48950140, 48950146, 48951070, 48951076, 48951080, 48951086, 48951090, 48951096, 48951100, 48951106, 48951110, 48951116, 48951120, 48951126, 48951130, 48951136, 48951140, 48951146, 48952070, 48952080, 48952090, 48952100, 48952110, 48952120, 48952130, 48952140, 48953070, 48953080, 48953090, 48953100, 48953110, 48953120, 48953130, 48953140, 48954076, 48954086, 48954096, 48954106, 48954116, 48954126, 48954136, 48954146, 48955076, 48955086, 48955096, 48955106, 48955116, 48955126, 48955136, 48955146, Vl/48950090, Vl/48953090, Vl/48955096, 48950066, 48954066, 48951092, 48951112, 48951132, 48950092, 48950112, 48950132, 48956086, 48956096, 48956106, 48956116, 48956126, 48956136, 48956146, 48956140, 48957092, 48957112, 48957132, 48956112, 48956132, 48952092, 48952112, 48952132, 48953092, 48953112, 48953132, 48950102, 48950122, 48950142, 48951102, 48951122, 48951142, 48956076, 48956092, 48956102, 48956122, 48956142, 48953102, 48953122, 48953142
  • UDI: 07613327117943
  • Distribution: US Nationwide

The hazard

The FDA said the recall addresses reports of cage fractures occurring both during and after surgery. The agency noted that the surgical technique is being updated to caution against misuse associated with these fractures.

Context

GovInfoNow's records show Howmedica Osteonics Corp. has issued 46 other recalls since July 21, 2017. Recent brand recalls include an OMNIFIT Series I Acetabular Insert recall on July 30, 2026, a Triathlon Baseplate Size 3 recall on May 19, 2026, and a MICS3 Angled Sagittal Saw Attachment recall on February 2, 2026. Other recent recalls of similar products include a Novapproach OneLIF Interbody Cage recall (April 23, 2026), an Olympus HX-400U-30 Ligating Device recall (October 30, 2025), and a Medline Spinal Fusion Kits recall (March 19, 2026).

How to tell if you have this one

Check the model numbers listed in the recall notice (e.g., 48950070, 48950076) and lot numbers. The implants are used in spinal fusion procedures and were sold under the brand Howmedica Osteonics Corp.

  • Brand
    Howmedica
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Contact Manufacturer

    Reach out to Howmedica Osteonics Corp. to confirm if your implant is affected and get instructions for next steps.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 18 months after the firm started it.

1. Firm started the recall: Nov 28, 201812. FDA classified it Class II: Dec 13, 201823. Published in FDA’s Enforcement Report: Dec 19, 201834. FDA terminated the recall: May 28, 2020420182020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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-0605-2019 (November 28, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0605-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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