Recall Z-1754-2015— Biomet, Inc.
Class III · Terminated
Class III FDA medical device recall by Biomet, Inc., initiated 2015-04-16, terminated 2016-05-16. It names 2 FDA 510(k) clearances: K030055, K003429. Product: Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- Metric Femoral Components. Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners.. Reason: Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes..
- Recalling firm
- Biomet, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2015-04-16
- Terminated
- 2016-05-16
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
2 on FDA's record- K030055 — MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS
- K003429 — MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- Metric Femoral Components. Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners.
Reason for recall
Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
Data sourced from openFDA. This site is unofficial and independent of the FDA.