Z-2397-2016 Class II Terminated
FDA device recall Z-2397-2016 was initiated by Zimmer Biomet Spine, Inc on June 30, 2016 and is designated Class II. Reason for recall: Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrument Case and Zyston¿ Transform Implant Kit because the locking mechanism on the implant is not functionin… The recall status is terminated (terminated March 15, 2017). Affected quantity: 5.
Recall Details
- Product Type
- Devices
- Report Date
- August 17, 2016
- Initiation Date
- June 30, 2016
- Termination Date
- March 15, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5
Product Description
Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
Reason for Recall
Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrument Case and Zyston¿ Transform Implant Kit because the locking mechanism on the implant is not functioning as intended.
Distribution Pattern
Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.
Code Information
Lot Numbers: 2016234237; 2016234240; 2016234242; 2016234243; 2016234245; 2016234246; 2016234247; 2016234248; 2016234249; 2016234351.