Z-0735-2019 Class II Terminated
FDA device recall Z-0735-2019 was initiated by Zimmer Biomet, Inc. on Nov 28, 2018 and is designated Class II. Reason for recall: There is a potential for silicone shedding during cleaning and sterilization. The recall status is terminated (terminated May 12, 2020). Affected quantity: 971 in total.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 23, 2019
- Initiation Date
- Nov 28, 2018
- Termination Date
- May 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 971 in total
Product Description
Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 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.
Distribution Pattern
Worldwide Distribution - US Nationwide, The products were distributed to the following foreign countries: Australia, Chile, Netherlands.
Code Information
Lot Numbers 453392 453918 453919 469917 475577 481064 481065 486820 498695 506818 512867 512868
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0735-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026