"***BIOMET 3i***4555 Riverside Drive Palm Beach Gardens FL 33410 USA***REF SWCA62***Conical Abutment Gold Standard ZR***
FDA device recall Z-0159-2012 · posted 2011-11-03 · Terminated
Recall details
- Recalling firm
- Biomet 3i, LLC
- Reason for recall
- On 09/28/2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Conical Angled Abutment, Model # AC4425 Lot 887628-5 and their Standard Conical Abutment Cylinder Model # SWCA62 Lot 848478. The packaging for the referenced products may not have been completely sealed prior to shipment.
- Action taken
- Biomet 3i, LLC sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 28, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were asked to inspect their inventory and return any affected product for replacement. A Product Recall Response Form was attached for customers to complete and return via fax to 561-514-6316. Customers are directed to call 1-800-342-5454 for questions regarding this recall.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- NHA
- Quantity affected
- 8
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Chile, Italy, Japan, Korea, Spain, and Sweden.
- Date initiated
- 2011-09-28
- Date posted
- 2011-11-03
- Date terminated
- 2012-03-09
- 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 |