Zimmer Biomet Caddy Recall: Silicone Shedding Risk During Sterilization
Zimmer Biomet recalls specific caddy models for potential silicone shedding during cleaning and sterilization. Affected units include lot numbers 453392 to 512868. Consumers should contact the company for details.
Lower-risk recall
There is a potential for silicone shedding during cleaning and sterilization.
Contact the company
What happened, in plain English
Zimmer Biomet is recalling certain caddy models used to carry surgical implants. The recall is due to a potential risk of silicone shedding during cleaning and sterilization processes, which could lead to contamination of surgical instruments. Read more at govinfonow.com/recall/69422-zimmer-biomet-caddy-recall-silicone-shedding-risk-during-sterilization.
Source Summary by GovInfoNow · govinfonow.com/recall/69422-zimmer-biomet-caddy-recall-silicone-shedding-risk-during-sterilization · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0735-2019
Cite this page
“Zimmer Biomet Caddy Recall: Silicone Shedding Risk During Sterilization.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69422-zimmer-biomet-caddy-recall-silicone-shedding-risk-during-sterilization. Based on FDA recall #Z-0735-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0735-2019%22&limit=1).
Why it’s dangerous
Silicone shedding can occur when the caddy is cleaned or sterilized, potentially contaminating surgical instruments. This contamination could lead to infections or other complications during procedures if the shed silicone comes into contact with instruments.
Who’s affected
Healthcare professionals who use these caddies for carrying surgical implants and instruments during hospital sterilization processes are most at risk. The recall affects specific lot numbers produced between certain dates.
How to tell if you have this one
Check the lot number on the caddy, which should be one of 453392, 453918, 453919, 469917, 475577, 481064, 481065, 486820, 498695, or 506818, 512867, 512868. These caddies are used in hospitals to carry surgical implants and instruments during inventory handling and sterilization.
- Brand
Zimmer Biomet- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide Distribution - US Nationwide, The products were distributed to the following foreign countries: Australia, Chile, Netherlands.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0734-2019 | 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; Lot Numbers 453392 453918 453919 469917 475577 481064 481065 486820 498695 506818 512868 | 971 i nTotal |
| Z-0735-2019 | 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; Lot Numbers 453392 453918 453919 469917 475577 481064 481065 486820 498695 506818 512867 512868 | 971 in total |
What to do — step by step
Check Lot Number
Identify the lot number on the caddy to determine if it is affected (453392, 453918, 453919, 469917, 475577, 481064, 481065, 486820, 498695, 506818, 512867, or 512868).
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - US Nationwide, The products were distributed to the following foreign countries: Australia, Chile, Netherlands.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0735-2019 (November 28, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0735-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.