Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallo
FDA device recall Z-1754-2015 · posted 2015-06-11 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
- Action taken
- Biomet sent an Urgent Medical Device Recall Notice letter dated April 29, 2015 to affected customers via Fed-Ex. The letter identifed the affected product, problem and actions to be taken. Customers were asked to complete the attached response form and return it along with recalled product to Biomet. For questions callt (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 1315
- Distribution
- Worldwide Distribution - US Nationwide in the states of AR, CA, IL, IN, PA, FL, KS, LA, WI, VA, MA, MD, NJ, UT, NC, TX, AL, MI, KY, OH, SD, MO, GA, NV, WA and the countries of: Europe, Canada, Japan,
- Date initiated
- 2015-04-16
- Date posted
- 2015-06-11
- Date terminated
- 2016-05-16
- 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 TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS (K030055) | Biomet, Inc. | 2003-08-11 |
| MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL (K003429) | Biomet, Inc. | 2000-11-30 |