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
Reported: January 23, 2019 Initiated: November 28, 2018 #Z-0735-2019
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.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 971 in total
- Distribution
- Worldwide Distribution - US Nationwide, The products were distributed to the following foreign countries: Australia, Chile, Netherlands.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Zimmer Biomet, Inc.. Units affected: 971 in total.
Why was this product recalled? ▼
There is a potential for silicone shedding during cleaning and sterilization.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 23, 2019. Severity: Moderate. Recall number: Z-0735-2019.
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