Z-1778-2022Class II

Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component

Name: Z-1778-2022 Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component
Creator: Howmedica Osteonics Corp.
Published: 2022-08-24
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2022-08-24 / Open, Classified

FDA source

Howmedica Osteonics Corp. began a recall of Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component on 2022-08-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1778-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-24
Posted: 2022-09-23
Recalling firm: Howmedica Osteonics Corp
Product: Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
Product code: KRQ Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: 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.
FDA 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 in commerce: 1 unit
Distribution: Distributed to one customer located in New York.
Product codes and lots: Lot number B24694 (no UDI)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1778-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1778-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-23

Product code KRQ

K140898Class IIPatient Specific Distal FemoralStanmore Implants Worldwide , Ltd. / cleared 2015-01-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)