Z-0087-2019 Class II Terminated
FDA device recall Z-0087-2019 was initiated by Orthosensor, Inc. on July 12, 2018 and is designated Class II. Reason for recall: Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. The recall status is terminated (terminated June 27, 2019). Affected quantity: 68 devices.
Recall Details
- Product Type
- Devices
- Report Date
- October 17, 2018
- Initiation Date
- July 12, 2018
- Termination Date
- June 27, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 68 devices
Product Description
OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R.
Reason for Recall
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Distribution Pattern
Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.
Code Information
Lot numbers 20566, 20567, 20609, and 20611, UDI 00816818021461.