Recall Z-1615-2014— Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Biomet, Inc., initiated 2014-04-22, terminated 2015-01-13. It names 2 FDA 510(k) clearances: K051385, K040611. Product: ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.. Reason: This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge ramp threads are missing from the stem, the likelihood of the set screw loosening from the radial stem intraoperatively is increased. If the set screw loosens, a revision surgery may be necessary..
- Recalling firm
- Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-22
- Terminated
- 2015-01-13
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
2 on FDA's record- K051385 — EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE
- K040611 — MODULAR RADIAL HEAD REPLACEMENT DEVICE
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
ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
Reason for recall
This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge ramp threads are missing from the stem, the likelihood of the set screw loosening from the radial stem intraoperatively is increased. If the set screw loosens, a revision surgery may be necessary.
Data sourced from openFDA. This site is unofficial and independent of the FDA.