Z-0625-2016 Class II Terminated
FDA device recall Z-0625-2016 was initiated by Zimmer Biomet, Inc. on Nov 17, 2015 and is designated Class II. Reason for recall: Zimmer Biomet is initiating a recall of the Virage Occipital Eyelet, as it was found through product testing that the staking of the set screw was out of specification and can interfere with the… The recall status is terminated (terminated Aug 12, 2016). Affected quantity: 372.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 20, 2016
- Initiation Date
- Nov 17, 2015
- Termination Date
- Aug 12, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 372
Product Description
Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3). UDI Number 889024328952
Reason for Recall
Zimmer Biomet is initiating a recall of the Virage Occipital Eyelet, as it was found through product testing that the staking of the set screw was out of specification and can interfere with the insertion of the occipital rod when the set screw is staked too low.
Distribution Pattern
US: AL, AZ, CA, CO, FL, GA, ID, MI, MN, MO, NV, NJ, OK, OR, PA, SD, TN, TX, WA, WI. OUS: AUSTRALIA, GERMANY, SWITZERLAND, SWEDEN.
Code Information
Lots: 62968065, 62947660, 62536230, 62745662, 62773482, 62758613, 62874869
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0625-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026