Biomet Recalls Endobon Xenograft Granules Due to Incorrect Batch Labels
Biomet 3i, LLC is recalling 704 units of Endobon Xenograft Granules 0.5 ML because individual pieces may have incorrect labels with the wrong batch number.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition indicates a low risk of adverse health consequences. The issue is a documentation/labeling error (wrong batch number) rather than a direct safety hazard like contamination or structural failure.
Plain-English summary
Biomet 3i, LLC is recalling 704 units of Endobon Xenograft Granules 0.5 ML, a bovine bone substitute used for implantation or transplantation during reconstructive surgery. The recall is due to a labeling error where individual pieces of the product may have incorrect labels displaying the wrong batch number.
The affected product is identified by Model # ROX05 and Batch # S0171051. The product was distributed worldwide, including in the United States (specifically CA, DC, FL, LA, MA, MO, NC, NJ, NY, TX, VA, WA, and Hawaii) and internationally to Austria, Belgium, Canada, Switzerland, Germany, Spain, France, Great Britain (UK), Ireland, Mexico, Poland, Portugal, and Singapore.
Healthcare providers and consumers should check their inventory for this specific model and batch number. If the product is found, it should be removed from use and returned to the manufacturer or a designated distributor in accordance with the recall instructions.
The recalled product
- Product
- ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for implantation or transplantation when bone is lost due to trauma or requested during reconstructive surgery.
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Bone Substitute
- Hazard
- Affected units
- 704
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 (2)
- Model # ROX05
- Batch # S0171051
Distribution
Related recalls
Same manufacturer · Biomet 3i, LLC
See all →- ModerateBiomet 3i Recalls BellaTek Titanium Abutments Due to Manufacturing Misalignment
FDA (Devices) · 2020-10-14
- HighBiomet 3i Recalls Misaligned BellaTek Encode Definitive Abutments
FDA (Devices) · 2020-10-14
- ModerateBiomet 3i Recalls BellaTek Abutments Due to Manufacturing Misalignment
FDA (Devices) · 2020-10-14
- ModerateBiomet 3i Recalls BellaTek Titanium Abutments Due to Manufacturing Misalignment
FDA (Devices) · 2020-10-14
- ModerateBiomet 3i Recalls Misaligned BellaTek Dental Abutments
FDA (Devices) · 2020-10-14
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