Recall Z-0386-2022— Activbody, Inc.
Class II · Ongoing
Class II FDA medical device recall by Activbody, Inc., initiated 2021-11-30. FDA's recall record names no specific 510(k) clearance for this event. Product: activforce 2 package labeling: Model: Activ5-M R 201-200563. Reason: Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2) Firm failing to register and list its medical devices with U.S. Food and Drug Administration..
- Recalling firm
- Activbody, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-11-30
- Firm location
- San Diego, CA, United States
Product description
activforce 2 package labeling: Model: Activ5-M R 201-200563
Reason for recall
Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2) Firm failing to register and list its medical devices with U.S. Food and Drug Administration.
Data sourced from openFDA. This site is unofficial and independent of the FDA.