Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1778-2022.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1778-2022.
Recall ongoing. Follow firm instructions.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Howmedica Osteonics Corp. or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1778-2022.
Howmedica Osteonics Corp.
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Howmedica Osteonics Corp. Recall FAQ
Howmedica Osteonics Corp. is the subject of a medical implants safety report: Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.. The notice was published on August 24, 2022 by the U.S. Food and Drug Administration (FDA). Approximately 1 units are potentially affected.