Short tibial bearing MK4 - Std recall
Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
Why was Short tibial bearing MK4 - Std recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot number B24694 (no UDI)
- Product
- Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 1 unit
- Distribution
- Distributed to one customer located in New York.
- Recall date
- October 5, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)