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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
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 →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- HighZimmer Biomet Recalls Endobon Xenograft Granules Due to Cytotoxicity Failure
FDA (Devices) · 2016-02-17
- ModerateOsteomed Recalls Osteovationex Bone Void Filler Due to Shelf-Life Error
FDA (Devices) · 2020-06-10
- LowCollagen Matrix Recalls BioMend Extend Due to Potential Packaging Error
FDA (Devices) · 2018-11-21
- HighBiomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Errors
FDA (Devices) · 2020-03-04
- ModerateOsteomed Recalls Osteovation RMX Injectable Bone Void Filler Kits
FDA (Devices) · 2020-06-10
- ModerateCobra EMG ET Tube Recalled Due to Incorrect Size Labeling
FDA (Devices) · 2024-09-04