Hip prosthesis components recalled for mislabeling with incorrect sizes and types
Corin TriFit hip prosthesis components from lot 467881 were mislabeled, with size 2 stems labeled as size 7 and vice versa. Surgeons could implant incorrect components during hip replacement surgery.
What this means for you
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 medical device recall involving significant labeling errors on hip prosthesis components that could result in incorrect surgical implantation. While no illnesses or injuries have been reported, the risk-of-harm nature of implanting mismatched prosthesis components justifies a High severity rating per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Corin Ltd is recalling TriFit hip prosthesis components from lot 467881 due to a labeling error. Units from one batch were mislabeled: some TriFit TS size 2 stems were incorrectly labeled as TriFit CF size 7 components, and some size 7 components were labeled as size 2 stems.
This labeling error could result in surgeons receiving and implanting prosthesis components that do not match what was ordered or intended for a specific patient's hip replacement surgery.
The recalled components were distributed nationwide. No illnesses or injuries have been reported in connection with this labeling error. Patients who have undergone hip replacement surgery and healthcare providers should review their records and consult with Corin Ltd regarding any components from this lot.
The recalled product
- Product
- Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS, REF 6961007. Hip prosthesis component.
- Manufacturer
- Corin Ltd
- 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 467881
Distribution
Part of a larger recall action
This product is one of 2 recalled by Corin Ltd 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 2 products in this recall →Related recalls
Same manufacturer · Corin Ltd
See all →- HighOrthopedic knee implant components mislabeled; size mix-up risk
FDA (Devices) · 2023-11-08
- HighUnity Total Knee System Inserts May Be Mislabeled With Wrong Size
FDA (Devices) · 2023-11-08
- HighCorin BIOLOX DELTA ceramic hip replacement heads mislabeled with incorrect sizes
FDA (Devices) · 2022-12-28
- HighCorin BIOLOX DELTA Ceramic Hip Implant Heads Recalled for Incorrect Size Labeling
FDA (Devices) · 2022-12-28
- HighKnee Prosthesis Devices Recalled for Potential Sterility Packaging Issue
FDA (Devices) · 2022-11-30
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02