Z-1615-2014 Class II Terminated
FDA device recall Z-1615-2014 was initiated by Biomet, Inc. on Apr 22, 2014 and is designated Class II. 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… The recall status is terminated (terminated Jan 13, 2015). Affected quantity: 8 devices.
Recall Details
- Product Type
- Devices
- Report Date
- May 21, 2014
- Initiation Date
- Apr 22, 2014
- Termination Date
- Jan 13, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 devices
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.
Distribution Pattern
US Nationwide Distribution in the states of NY, MD, NC, SC, MI, OR, and NV.
Code Information
Catalog Number: 11-210062 Lot Number Identification: 972230
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1615-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026