Zimmer Biomet A.L.P.S. Calcaneus Plate Guide Inserts Recall: Incorrect Color Anodization
Zimmer Biomet recalls A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts with incorrect color anodization. Affected items have specific item numbers and package lots. No immediate action needed.
Lower-risk recall
The drill guides were manufactured with the incorrect color anodization.
Contact the company
What happened, in plain English
Zimmer Biomet is recalling certain A.L.P.S. Calcaneus Locking Plate guide inserts due to incorrect color anodization during manufacturing. This issue does not pose a safety risk but may affect product appearance or identification. Read more at govinfonow.com/recall/72666-zimmer-biomet-a-l-p-s-calcaneus-plate-guide-inserts.
Source Summary by GovInfoNow · govinfonow.com/recall/72666-zimmer-biomet-a-l-p-s-calcaneus-plate-guide-inserts · Updated September 14, 2026 · FDA enforcement record: FDA #Z-1306-2018
Cite this page
“Zimmer Biomet A.L.P.S. Calcaneus Plate Guide Inserts Recall: Incorrect Color Anodization.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72666-zimmer-biomet-a-l-p-s-calcaneus-plate-guide-inserts. Based on FDA recall #Z-1306-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1306-2018%22&limit=1).
Why it’s dangerous
The drill guides were made with the wrong color anodization, which could lead to confusion during identification or use. However, this does not cause injury or malfunction in normal medical procedures.
Who’s affected
Orthopedic surgeons and medical professionals who use these specific guide inserts for foot and ankle procedures. Patients are not at risk as the issue is cosmetic.
How to tell if you have this one
Check for item number 816209003 and package lot 989430 on the product. The lot number is etched as P0284 on the item itself.
- Brand
Zimmer Biomet- Category
Medical device
What to do — step by step
Check Product Details
Verify the item number and package lot on the guide inserts to confirm if they are affected.
Where it went and when
Where it was distributed
Distributed in 8 states, and outside the U.S.
FDA distribution: “Distributed in the following US States: AZ, MO, MT, NJ, NY, OH, TX, and WA. Distributed in Chile and Netherlands.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Missouri, Montana, New Jersey, New York, Ohio, Texas, Washington.
Recall timeline
FDA terminated this recall 2.5 years 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.
Questions people ask
Do I need to stop using these inserts?
No action is required. The recall is for identification purposes only, and the inserts can be used safely.
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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-1306-2018 (October 25, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1306-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 14, 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.