Dania, FL, United States
Orthosensor, Inc. recalls
1 recall recorded since 2018, most recently on 12 July 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 12 July 2018
- Terminated
- 27 June 2019
- Reason
- Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
- Distribution
- Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0082-2019, Z-0087-2019, Z-0083-2019, Z-0085-2019, Z-0084-2019, Z-0086-2019
- OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.
- OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R.
- OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R.
- OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.
- OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD39-L.
- OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSNCRGH712-L.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.