BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use
FDA device recall Z-2594-2014 · posted 2014-09-05 · Terminated
Recall details
- Recalling firm
- Biomet 3i, LLC
- Reason for recall
- Identifiers on the label are correct but the label has the incorrect color coding.
- Action taken
- Biomet 3i sent an Urgent - Medical Device Removal letter / and by phone call on and dated June 25, 2014, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. If you have any Certain BellaTek Encode Healing Abutment(s) of the affected lot in your practice, please return the abutment(s) to BIOMET 3i in exchange for Cettain BellaTek Encode Healing Abutments, IEHA458 with a proper color stripe. Alternatively, you may return the Certain BellaTek Healing Abutment(s) for full credit. We also ask that you confirm receipt of this notification by completing the attached Recall Return Response Form, indicating your preference for replacement or credit and/ or notifying us if the product was used. Thank you for your support - we are committed to maintaining high standards of quality for all our products and apologize for any inconvenience this may have caused you. If you have any further questions, please contact Customer Service at 1-800-342-5454 for assistance.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- NHA
- Quantity affected
- 6 units
- Distribution
- US Distribution to NH and TX.
- Date initiated
- 2014-06-25
- Date posted
- 2014-09-05
- Date terminated
- 2014-09-23
- Location
- Palm Beach Gardens, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS (K072642) | Biomet 3i, Inc. | 2007-12-20 |