Certain Low-Profile, Angled Abutment, Model Number ILPAC3217. Product is labeled in part: "***Biomet 3i***4555 Riverside
FDA device recall Z-1456-2012 · posted 2012-04-25 · Terminated
Recall details
- Recalling firm
- Biomet 3i, LLC
- Reason for recall
- Biomet 3i initiated a recall for a small percentage of the 33mm (ILPAC3217) abutment packages that may contain the 5mm (ILPAC5217) abutment.
- Action taken
- Biomet 3i , LLC sent Urgent: Medical Device Recall notices on 1/10/2012 to each customer in via e-mail, facsimile, telephone or postal mail. The letters identified the affected product and the reason for the recall. Each customer was instructed to check their respective inventory for the affected product and return any unused product to Biomet 3i at the address provided. Biomet 3i will issue replacement product at no charge. Questions or concerns should be directed to 1-800-342-5454.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- NHA
- Quantity affected
- 400
- Distribution
- Worldwide Distribution -- Canada, Chile, Columbia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Singapore, South Africa, Spain, Sweden, Switzerland, UK
- Date initiated
- 2012-01-10
- Date posted
- 2012-04-25
- Date terminated
- 2012-04-30
- Location
- Palm Beach Gardens, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION (K092341) | Biomet 3i, Inc. | 2009-11-30 |