Matrix Surgical Recalls Mislabelled Mandible Onlay Implants
Matrix Surgical Holdings is recalling 28 mandible onlay implants due to packaging mislabeling where left-sided packaging contained right-sided devices.
What this means for you
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: The recall is classified as FDA Class II and involves a minor labeling error (mislabeling) with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Matrix Surgical Holdings, LLC is recalling 28 units of OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right. The recall is due to a mislabeling error where packaging labeled as containing a left mandible actually contained a right mandible.
The affected products were distributed worldwide to Brazil, Chile, Colombia, Norway, Saudi Arabia, South Africa, Sweden, and Taiwan. The specific lot numbers involved are 00855421005666 01211086 for the OP7543 and 00855421005673 013110816 for the OP7544.
Healthcare providers and consumers should stop using these specific lots and contact Matrix Surgical Holdings for further instructions or replacement.
The recalled product
- Product
- OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
- Manufacturer
- Matrix Surgical Holdings, LLC
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 28
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)
- OP7543 (lot 00855421005666 01211086) and OP7544 (lot 00855421005673 013110816)
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Matrix Surgical Holdings, LLC
See all →- ModerateMatrix Surgical Recalls 42 OmniPore Implants Due to Mislabeling
FDA (Devices) · 2019-05-08
- ModerateMatrix Surgical Recalls 46 OmniPore Implants Due to Mislabeling
FDA (Devices) · 2019-05-08
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