Recall Z-0734-2019— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-11-28, terminated 2020-05-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals. Reason: There is a potential for silicone shedding during cleaning and sterilization..
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-11-28
- Terminated
- 2020-05-12
- Firm location
- Warsaw, IN, United States
Product description
Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals
Reason for recall
There is a potential for silicone shedding during cleaning and sterilization.
Data sourced from openFDA. This site is unofficial and independent of the FDA.