Biomet Orthopedics DCM AGC Molded Tibial Component, 12 mm thick x 80 mm, UHMWPE/CO-CR-MO alloy, sterile; REF 155116.
FDA device recall Z-0077-2008 · posted 2007-10-31 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- Incorrect Product -- Mislabeled as to size; a 18 mm x 65 mm tibula implant is enclosed in a package labeled as 12 mm x 80 mm.
- Action taken
- The firm notified distributor by phone on or about 7/24/07 and followed up with an Urgent Medical Device Recall Notice/Letter dated 8/31/07. The letter requested that the product be discontinued and returned to Biomet.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 1
- Distribution
- Class II Recall - Worldwide Distribution --- USA including states of IA, SD, and countries of Brazil and Chile.
- Date initiated
- 2007-07-24
- Date posted
- 2007-10-31
- Date terminated
- 2008-07-24
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT (K921182) | Biomet, Inc. | 1993-07-23 |