FDA Medical Device Recalls (openFDA)
Howmedica Osteonics Corp.: Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
- Recall number
- Z-1778-2022
- Recalling firm
- Howmedica Osteonics Corp.
- Product
- Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
- Status
- Open, Classified
- Initiated
- 2022-08-24
- Posted
- 2022-09-23
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- On August 24, 2022, the firm sent written notification (Product Field Action) to the single affected customer to document the event. The customer was asked to confirm their receipt of the notice.
- Quantity
- 1 unit
- Distribution
- Distributed to one customer located in New York.
- Lot, serial or model codes
- Lot number B24694 (no UDI)
- 510(k) numbers
- ["K140898"]
- PMA numbers
- not on file
- Product code
- KRQ
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28