Z-0609-2014 Class II Terminated
FDA device recall Z-0609-2014 was initiated by Zimmer, Inc. on Dec 10, 2013 and is designated Class II. Reason for recall: Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the… The recall status is terminated (terminated Sep 11, 2014). Affected quantity: 25.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 8, 2014
- Initiation Date
- Dec 10, 2013
- Termination Date
- Sep 11, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution -USA including OH, FL, WI, MI NJ, SC, CA, NC, PA, OR, WA, TN, KY, OK, KS, AZ, TX, CO, NV and Internationally to Germany. There have been 71 distribution events. Note that this product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf. 7 units have been returned, including three through the complaint process, which leaves 64 affected units in the field subject to removal.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0609-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026