Biomet Interlok 75 MM fixed I-Beam Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V ALLOY, REF 141224, Sterile, BIOMET O
FDA device recall Z-2104-2011 · posted 2011-04-28 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The firm is recalling the product due to the product's packaging being labeled "I-Beam 75mm. Tibial Plate", but the package actually contains the "Interlok 67mm. CR Tibial Plate".
- Action taken
- Biomet Orthopedics Inc initiated an electronic communication with Direct Accounts on March 3, 2011 and instructed them to quarantine and return all remaining/unused devices to the firm. For questions regarding this recall call 574-372-3983.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 8
- Distribution
- Worldwide Distribution -USA including FL, IN, and NC and the countries of Japan and the Netherlands
- Date initiated
- 2011-03-03
- Date posted
- 2011-04-28
- Date terminated
- 2011-07-27
- Location
- Warsaw, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM (K915132) | Biomet, Inc. | 1992-02-11 |