BIOMET 3i, EP Healing Abutment, REF/Item Number: THA53, 4.1mm(D) X 5mm(P) X 3mm(H), Sterile, BIOMET 3i, Palm Beach, FL
FDA device recall Z-1366-2008 · posted 2008-03-29 · Terminated
Recall details
- Recalling firm
- Biomet 3i, Inc.
- Reason for recall
- Mis-labeling: Labeled THA53 device packaging may contain ITHA53 devices (The ITHA53 is designed to be used with an internally hexed implant--The THA53 is used with an external hex platform)
- Action taken
- Each USA customer was first contacted by telephone and then with a faxed, Urgent Medical Device Recall letter, dated 2/25/2008. Each International customer was first contacted by E-mail and then with a faxed letter. They were instructed to return the affected product to Biomet 3i.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NHA
- Quantity affected
- 254
- Distribution
- Worldwide
- Date initiated
- 2008-02-14
- Date posted
- 2008-03-29
- Date terminated
- 2008-07-10
- 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 |
|---|---|---|
| BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS (K072642) | Biomet 3i, Inc. | 2007-12-20 |