***REF IOSS511***OSSEOTITE Certain Implant 5 x 11.5mm***LOT 910695***Sterile using Radiation***Rx Only***BIOMET 3i Denta
FDA device recall Z-0171-2012 · posted 2011-11-08 · Terminated
Recall details
- Recalling firm
- Biomet 3i, LLC
- Reason for recall
- The product may contain a manufacturing defect, that if present, may prevent the driver; cover screw or abutment from fully engaging the implant.
- Action taken
- The firm sent an Urgent: Medical Device Recall letter, dated November 2010, to notify customers that received the Osseotite Certain Implant (IOSS511) of the problem. The customers were instructed to return the unopened device(s) to Biomet 3i for replacement. If customers notice an issue, they were to contact Customer Service at 1-800-342-5454 for assistance. Customers were to respond via fax and return the implant(s) to BIOMET 3i using the address and incident number provided. Customers with questions or concerns were instructed to contact Mark Mashburn at 561-776-6906.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 241
- Distribution
- Worldwide Distribution -- USA , BR, JP, TW, CA, Germany, and Guam.
- Date initiated
- 2010-11-18
- Date posted
- 2011-11-08
- Date terminated
- 2011-11-09
- 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 |