Incompatible tibial bearing supplied for knee prosthesis installation
An MK4 tibial bearing knee implant component was mistakenly supplied when an MK3 model was required. The mismatch was discovered during surgery and corrected by the surgeon.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall involving a device component mismatch discovered during surgery. No adverse events, injuries, or hospitalizations are mentioned in the source.
Plain-English summary
Howmedica Osteonics Corp. is recalling one MK4 Short Tibial Bearing (Catalog No. SMMLTB02, Lot B24694) distributed to a healthcare customer in New York. The device was supplied with the intent to be compatible with a Tibial Metal Casing but the patient's existing casing was an MK3 model. The MK4 bearing is not compatible with the MK3 casing and cannot be substituted for it.
The incompatibility was discovered during surgery. The surgeon removed the MK4 bearing and completed the procedure by re-assembling and re-inserting the patient's original MK3 tibial bearing.
This recall is issued to alert the healthcare provider and relevant parties to ensure proper device model verification during implant selection to prevent similar incidents.
The recalled product
- Product
- Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number B24694 (no UDI)
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Howmedica Osteonics Corp.
See all →- ModerateHowmedica Recalls Triathlon Hinge Femoral Prep Trays Due to Moisture Risk
FDA (Devices) · 2026-10-21
- ModerateHowmedica Recalls Triathlon Universal Baseplate Finishing Trays Due to Moisture Risk
FDA (Devices) · 2026-10-21
- ModerateHowmedica Triathlon Instrument Trays Recalled for Sterilization Dry Time Issue
FDA (Devices) · 2026-10-21
- ModerateHowmedica Recalls TS Femoral Prep Trays Due to Sterilization Instructions
FDA (Devices) · 2026-10-21
- HighHowmedica Recalls Orthopaedic Implant Components Due to Material Aging
FDA (Devices) · 2026-09-23
Same hazard · device incompatibility
See all →- CriticalMonoject Insulin Syringes Recalled for Incompatibility with Needleless IV Connectors
FDA (Devices) · 2024-11-20
- HighPERIFIX epidural kits recalled for incompatible filter straw connectors
FDA (Devices) · 2024-02-28
- SevereCardinal Health Monoject Enteral Syringes Recalled for Pump Incompatibility
FDA (Devices) · 2024-02-14
- SevereCardinal Health Enteral Syringes Recalled for Pump Incompatibility
FDA (Devices) · 2024-02-14
- SevereEnteral Syringes Recalled for Incompatibility with Feeding Pumps
FDA (Devices) · 2024-02-14
Similar recalls
- HighKnee Replacement Insert Mislabeled; Contents May Not Match Catalog Number
FDA (Devices) · 2023-06-07
- HighKnee replacement implant bearing inserts mislabeled with wrong catalog numbers
FDA (Devices) · 2023-06-07
- HighKnee replacement tibial insert recalled for potential material oxidation
FDA (Devices) · 2024-02-07
- HighEVOLUTION MP Tibial Base knee component recalled for wrong product in packaging
FDA (Devices) · 2023-02-22
- HighBiomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw
FDA (Devices) · 2013-07-17
- HighSeries II Tibial Bear Insert Recalled for Potential Material Degradation
FDA (Devices) · 2024-02-07