Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The product is sterile. Product provide
FDA device recall Z-0298-2013 · posted 2012-11-16 · Terminated
Recall details
- Recalling firm
- Biomet 3i, LLC
- Reason for recall
- Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too shallow. This condition may prevent the driver or abutment from fully engaging in the implant.
- Action taken
- Biomet 3i sent an "URGENT: MEDICAL DEVICE RECALL" letter dated September 28, 2012. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-342-5454 for questions regarding this notice.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 76 devices
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of VA, SC, HI, LA, OH, FL, IL, NJ, NC, CA, CT, MI, TN, AK, NH, NY, MA, GA, PA, and KY and the countries of United Kingdom, Spain, Germany,
- Date initiated
- 2012-09-28
- Date posted
- 2012-11-16
- Date terminated
- 2015-08-06
- Location
- Palm Beach Gardens, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OSSEOTITE II MODEL XIFOSSXXX (K100724) | Biomet 3i, Inc. | 2011-04-01 |