Zimmer Biomet Recalls Compression Tray Bases Due to Silicone Shedding
Zimmer Biomet is recalling 971 Maximum Variable Pitch Compression Tray Bases because they may shed silicone during cleaning and sterilization.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 971 units of the Maximum Variable Pitch Compression Tray Base, Reference Number 231201002. These trays are intended to carry implants and instruments during regular inventory distribution, handling, and sterilization in hospitals.
The recall is being conducted because there is a potential for silicone shedding during the cleaning and sterilization processes. The affected products were distributed worldwide, including in the United States, Australia, Chile, and the Netherlands. The specific lot numbers involved are 453392, 453918, 453919, 469917, 475577, 481064, 481065, 486820, 498695, 506818, and 512868.
Hospitals and healthcare facilities should stop using these specific tray bases and contact Zimmer Biomet for further instructions on how to proceed with the recall.
The recalled product
- 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
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 971
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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Same hazard · material shedding
See all →- HighZimmer Biomet Recalls Maximum Variable Pitch Compression Screw Caddy
FDA (Devices) · 2019-01-23
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