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.
What this means for you
Illness, injury, or structural failure has been reported. 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
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