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.
A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ. However, the device in-situ was a MK3 Tibial Metal Casing. 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.
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.
The MK4 tibial bearing was designed to work with a different tibial casing than what was supplied. When installed, it won't match the MK3 casing, requiring the surgeon to reassemble the knee joint during surgery. This increases the risk of surgical complications if not handled properly.
Patients who received this specific knee prosthesis component during surgery are affected. Surgeons who used the recalled part during procedures are most at risk of needing additional surgical steps.
Check for the catalog number SMMLTB02 on the product label. The affected items were sold with lot number B24694 (no UDI).
Reach out to Howmedica Osteonics Corp. for guidance on next steps after identifying the recalled component.
The MK4 tibial bearing was supplied with the intention to mate with the MK3 tibial casing, but it is not exchangeable with the MK3 casing, requiring reassembly during surgery.
No, the recall does not require stopping use. Surgeons must reassemble the knee joint during surgery if the recalled component is used.
Check for catalog number SMMLTB02 and lot number B24694 on the product label.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-1778-2022 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-1778-2022 from Howmedica. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.