Hip Implant Acetabular Shell Recalled for Manufacturing Defect
Howmedica Osteonics is recalling TRIDENTII HEMI CLUSTER50D hip implant shells due to excessive deburring that may create a smooth edge, potentially affecting implant fit. Affected units were distributed nationwide and internationally.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a critical orthopedic medical device with a manufacturing defect that could affect implant function and stability. No illnesses or injuries have been reported to date.
Plain-English summary
Howmedica Osteonics Corp. is recalling the TRIDENTII HEMI CLUSTER50D acetabular shell component of hip implants due to a manufacturing defect. The acetabular shell may undergo excessive deburring during production, resulting in a smooth surface on the edge of the shell rather than the intended surface finish.
The product is indicated for use in primary and revision patients at high risk of hip dislocation. The smooth edge from excessive deburring may affect the proper fit and function of the implant.
The recall affects TRIDENTII HEMI CLUSTER50D units (Catalog Number 702-11-50D) with the following lot numbers: 14629051, 14628851, 15175654, and 15610452. These units were distributed nationwide in the United States and to the Netherlands, Canada, Singapore, Spain, Sweden, and the United Kingdom.
Patients who have received this implant should contact their healthcare provider to determine if their device is affected and discuss any necessary follow-up care.
The recalled product
- Product
- TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-50D
- Manufacturer
- Howmedica Osteonics Corp.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →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 · manufacturing defect
See all →- ModerateBoston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
- ModerateCook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
FDA (Devices) · 2026-10-21
- ModerateNeuronetics Recalls NeuroStar Advanced Therapy Systems Due to Non-Conforming Cables
FDA (Devices) · 2026-10-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
Similar recalls
- HighTriathlon orthopaedic implant baseplate recalled for assembly defect
FDA (Devices) · 2021-08-25
- ModerateStryker Howmedica Hip Prosthesis Components Recalled for Seal Defects
FDA (Devices) · 2015-05-27
- HighUNITRAX Hip Implant Head Component Recalled for Package Label Size Mismatch
FDA (Devices) · 2024-07-24
- HighStryker Recalls PCA Acetabular Inserts Due to Regulatory Omission
FDA (Devices) · 2015-11-25
- HighExeter V40 Cemented Hip Stem Recalled for Potential Label Mix-Up
FDA (Devices) · 2022-02-23
- HighHowmedica Recalls Orthopaedic Implants Due to Aged Polyethylene Material
FDA (Devices) · 2026-09-23