Biomet Recalls Discovery Elbow Prosthesis Due to Surface Finish Defect
Biomet, Inc. is recalling one unit of a Discovery Elbow prosthesis because the surface finish differs from specifications, potentially causing pain requiring surgery.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states that the patient may experience pain requiring surgical intervention, which aligns with the rubric criteria for Severe severity involving significant injury or hospitalization reports.
Plain-English summary
Biomet, Inc. is recalling one unit of the Discovery Elbow prosthesis, specifically the 4 MM X 100 MM Right Humeral Flanged I Bond Coat Ti 6Al 4V Alloy. The recall is due to a manufacturing defect where the implant's exterior flange has a 30 grit blast finish instead of the specified glass bead blast.
The affected product is a medical device intended for primary and revision joint arthroplasty in cemented applications. The distribution was limited to the state of California. The specific unit is identified by Catalog/REF # 114905 and Lot # M846640.
Patients who have received this specific implant may experience pain that requires surgical intervention. Healthcare providers and patients should contact Biomet, Inc. for further instructions regarding the recall and potential corrective actions.
The recalled product
- Product
- DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement prostheses are intended for primary and revision joint arthroplasty for use in cemented applications.
- Manufacturer
- Biomet, Inc.
- 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 (2)
- Catalog/REF #: 114905
- Lot #: M846640
Distribution
Related recalls
Same manufacturer · Biomet, Inc.
See all →- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recall for Packaging Damage
FDA (Devices) · 2026-08-12
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighBiomet Recalls Discovery Elbow Humeral Trial Due to Incorrect Etching
FDA (Devices) · 2014-10-22
- HighBiomet 3i Recalls Bellatek Encode Healing Abutments Due to Fit Issues
FDA (Devices) · 2020-03-04
- HighBiomet Shoulder Stem Implants Recalled for Coating Adhesion Defect
FDA (Devices) · 2022-03-02
- ModerateBiomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error
FDA (Devices) · 2020-03-04
- ModerateZimmer Biomet Recalls Coonrad/Morrey Elbow Replacement Kits Due to Missing Parts
FDA (Devices) · 2016-09-14
- HighBiomet Shoulder Implant Stem Coating Adhesion Defect Recall
FDA (Devices) · 2022-03-02