Recall Z-1615-2014 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Biomet, Inc.
ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
| Date | May 13, 2014 (initiated Apr 22, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 8 devices |
| Distribution | US Nationwide Distribution in the states of NY, MD, NC, SC, MI, OR, and NV. |
| FDA record | Open on fda.gov |