Zimmer Biomet Recalls Maximum Variable Pitch Compression Screw Caddy
Zimmer Biomet is recalling 971 Maximum Variable Pitch Compression Screw Caddies due to a potential for silicone shedding 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 'High' severity criteria for potential hazards without confirmed illness.
Plain-English summary
Zimmer Biomet, Inc. is recalling 971 units of the Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003. The product is intended to carry implants and instruments during regular inventory distribution, handling, and sterilization in hospitals.
The recall was initiated because there is a potential for silicone shedding during the cleaning and sterilization processes. The affected products were distributed worldwide, including nationwide in the United States and in Australia, Chile, and the Netherlands. The specific lot numbers involved are 453392, 453918, 453919, 469917, 475577, 481064, 481065, 486820, 498695, 506818, 512867, and 512868.
Hospitals and medical facilities should stop using the affected caddies and contact Zimmer Biomet for instructions on how to return or dispose of the products.
The recalled product
- Product
- 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
- 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 Compression Tray Bases Due to Silicone Shedding
FDA (Devices) · 2019-01-23
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