Mallory Head Calcar Provisional, 45 mm replacement stem, 13.0 x 220 mm left, Sterile, REF 104986, Biomet Orthopaedics, W
FDA device recall Z-1666-2010 · posted 2010-05-26 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep.
- Action taken
- Biomet Orthopedics issued an "Urgent Medical Device Recall Notice" dated March 10, 2010. The letter went to distributors and users of the recalled device. The letter instructed the consignees to locate the recalled product and return the product to the firm. For further information, contact Biomet at 1-800-348-9500 or 1-574-372-3983, Monday through Friday, 8:00 AM to 5:00 PM.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 6
- Distribution
- Worldwide Distribution -- United States (OH, IN, FL, KY, NV and CA), Mexico, Chile, China, Japan and The Netherlands.
- Date initiated
- 2010-03-10
- Date posted
- 2010-05-26
- Date terminated
- 2010-10-18
- 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 |
|---|---|---|
| MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA (K031693) | Biomet, Inc. | 2003-08-06 |