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Use caution Medical device recall · FDA · Published August 24, 2022

Howmedica Short Tibial Bearing MK4 Knee Prosthesis Recall: Incompatible with MK3 Casing

Howmedica recalls Short Tibial Bearing MK4 (Catalog SMMLTB02) due to incompatibility with MK3 Tibial Metal Casing, requiring surgical reassembly. Affected patients should contact Howmedica for guidance.

🇺🇸 FDA recall #Z-1778-2022Medical deviceHowmedica ›
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Contact the company

Recalling firmHowmedica Osteonics Corp.325 Corporate Dr · Mahwah, NJ 07430-2006
✎ GovInfoNow plain-language explainer

Howmedica is recalling certain knee prosthesis components because the MK4 tib:ibial bearing won't fit with the MK3 tibial casing. This means surgeons must reassemble the knee joint during surgery, which could lead to complications if not handled correctly. Read more at govinfonow.com/recall/60133-howmedica-short-tibial-bearing-mk4-knee-prosthesis-recall-incompatible-with.

Source Summary by GovInfoNow · govinfonow.com/recall/60133-howmedica-short-tibial-bearing-mk4-knee-prosthesis-recall-incompatible-with · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1778-2022

Cite this page

“Howmedica Short Tibial Bearing MK4 Knee Prosthesis Recall: Incompatible with MK3 Casing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60133-howmedica-short-tibial-bearing-mk4-knee-prosthesis-recall-incompatible-with. Based on FDA recall #Z-1778-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1778-2022%22&limit=1).

The FDA announced on Aug. 24, 2022, that Howmedica Osteonics Corp. is recalling Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02 knee prosthesis components due to a hazard involving incompatible mating parts. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: Howmedica
  • Product: Short tibial bearing MK4 - Std, STM
  • Catalog No.: SMMLTB02
  • Lot number: B24694

The hazard

The recalled MK4 Tibial Bearing was supplied to mate with a Tibial Metal Casing in-situ, but the device in-situ was actually a MK3 Tibial Metal Casing. Because the supplied MK4 tibial bearing was not exchangeable for the MK3 tibial bearing, the surgeon needed to complete the surgery by re-assembling and re-inserting the extracted MK3 tibial bearing.

Context

GovInfoNow's records show Howmedica Osteonics Corp. has 46 other recalls on record since July 21, 2017. Other recent recalls of similar products include Orthopedic Implant Bushings Due to Oxidation Risk (July 30, 2026), Triathlon Baseplate Size 3 Recall (May 19, 2026), and MICS3 Angled Sagittal Saw Attachment Recall (Feb. 2, 2026). Other recent recalls of similar products include Encore Medical EMPOWR 3D Knee Tibial Insert 5R 14MM Recall (Jan. 5, 2026) and U2 Total Knee System Femoral Valgus Adaptor Recall (May 20, 2026).

How to tell if you have this one

Check for the catalog number SMMLTB02 on the product label. The affected items were sold with lot number B24694 (no UDI).

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

What to do — step by step

  1. Contact Howmedica

    Reach out to Howmedica Osteonics Corp. for guidance on next steps after identifying the recalled component.

Where it went and when

Where it was distributed

Distributed in New York.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “Distributed to one customer located in New York.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: New York.

Recall timeline

FDA published this recall 42 days after the firm started it.

1. Firm started the recall: Aug 24, 202212. FDA classified it Class II: Sep 23, 202223. Published in FDA’s Enforcement Report: Oct 5, 202232022
  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-1778-2022 (August 24, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1778-2022 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