ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
FDA device recall Z-1615-2014 · posted 2014-05-13 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- 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.
- Action taken
- Biomet sent an URGENT MEDICAL DEVICE SAFETY ALERT dated April 22, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KWI
- Quantity affected
- 8 devices
- Distribution
- US Nationwide Distribution in the states of NY, MD, NC, SC, MI, OR, and NV.
- Date initiated
- 2014-04-22
- Date posted
- 2014-05-13
- Date terminated
- 2015-01-13
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE (K051385) | Biomet, Inc. | 2005-08-05 |
| MODULAR RADIAL HEAD REPLACEMENT DEVICE (K040611) | Biomet, Inc. | 2004-06-04 |