Biomet Biolox-Delta Modular Ceramic Head, 28 mm head diameter, plus 5 neck, type 1, taper, sterile, Biomet Orthopedics,
FDA device recall Z-1613-2009 · posted 2009-07-14 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The firm has received reports of fractured heads, requiring revision surgery.
- Action taken
- Biomet Orthopedics issued an "Urgent Medical Device Recall Notice" dated March 16, 2009 to users describing the affected device. Consignees were instructed to locate and discontinue use of the product and quarantine until a sales representative can arrange for removal. Consignees were also asked to complete and return the attached "Fax-Back Response Form" to Biomet at 1-574-372-1683. Further questions can be directed to Biomet Orthopedics at 1-800-348-9500.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LZO
- Quantity affected
- 174
- Distribution
- Worldwide Distribution -- US including PR and states of AZ, AL, AR, CA, CO, FL, IL, IN, KY, KS, MA, MI, LA, NY, SD, GA, MN, PA, NJ, MD, MI, OH, ME, TX, WA, WI and VA and countries of Australia, Belgiu
- Date initiated
- 2009-03-16
- Date posted
- 2009-07-14
- Date terminated
- 2010-10-06
- 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 |
|---|---|---|
| BIOLOX DELTA CERAMIC HEADS (K042091) | Biomet, Inc. | 2005-03-25 |