Zimmer Biomet Gentle Thread PLGA Screws Recalled Due to Mixing Risk
Zimmer Biomet recalls specific PLGA screws (item 905629) that may have been mixed with other models, posing a risk of incorrect use in medical procedures.
Lower-risk recall
The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.
Contact the company
What happened, in plain English
Zimmer Biomet is recalling certain PLGA interference screws that may have been mixed with other screw models. This could lead to incorrect surgical use if the wrong screw is used during procedures. Read more at govinfonow.com/recall/70328-zimmer-biomet-gentle-thread-plga-screws-recalled-due-to-mixing.
Source Summary by GovInfoNow · govinfonow.com/recall/70328-zimmer-biomet-gentle-thread-plga-screws-recalled-due-to-mixing · Updated August 20, 2026 · FDA enforcement record: FDA #Z-3177-2018
Cite this page
“Zimmer Biomet Gentle Thread PLGA Screws Recalled Due to Mixing Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70328-zimmer-biomet-gentle-thread-plga-screws-recalled-due-to-mixing. Based on FDA recall #Z-3177-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3177-2018%22&limit=1).
Why it’s dangerous
The screws may have been mixed with other models, potentially causing incorrect use during surgery. This could lead to complications if the wrong screw is implanted.
Who’s affected
Medical professionals who use these screws for surgery are likely affected. Patients receiving these screws during procedures may be at risk if the wrong model is used.
How to tell if you have this one
Check for item number 905629 on the screw packaging. The lot number 625450 and UDI code 00880304421066(17)221019(10)625450 are also associated with this recall.
- 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
The products were distributed to the following US states: IN, TN. The products were distributed to the following foreign countries: Australia, Chile, Netherlands.
| Recall number | Product, codes & lots |
|---|---|
| Z-3176-2018 | Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612; Lot Number 611330, UDI (1)00880304008526(17)221010(10)611330 |
| Z-3177-2018 | Gentle Thread PLGA Full Thread Interference Screw, 10x30mm, Item Number 905629; Lot Number 625450, UDI (1)00880304421066(17)221019(10)625450 |
What to do — step by step
Check Product Details
Look for item number 905629 on the screw packaging or check the lot number 625450 and UDI code provided.
Where it went and when
Where it was distributed
Distributed in Indiana and Tennessee, and outside the U.S.
FDA distribution: “The products were distributed to the following US states: IN, TN. 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.
States: Indiana, Tennessee.
Recall timeline
FDA terminated this recall 23 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.
Questions people ask
Are these screws dangerous if used correctly?
The recall is due to potential mixing with other models, not inherent danger if used correctly.
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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-3177-2018 (July 20, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3177-2018 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.