Lower risk Medical device recall · FDA · Published March 28, 2018

Zimmer Biomet Gentle Threads Interference Screw Recall: Overexposure Risk

Zimmer Biomet recalls specific lots of Gentle Threads Interference Screw (Model 905604) due to potential infection from overexposure during EtO sterilization.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1735-2018Medical device Zimmer Biomet ›

Lower-risk recall

Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.

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Contact the company

Recalling firmZimmer Biomet, Inc.56 E Bell Dr · Warsaw, IN 46582-6989

✎ GovInfoNow plain-language explainer

Zimmer Biomet is recalling specific lots of Gentle Threads Interference Screw (Model 905604) used in ankle/foot and knee procedures because overexposure during EtO sterilization may cause infection. This recall affects patients who received the device from specific lots. Read more at govinfonow.com/recall/71592-zimmer-biomet-gentle-threads-interference-screw-recall-overexposure-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/71592-zimmer-biomet-gentle-threads-interference-screw-recall-overexposure-risk · Updated August 21, 2026 · FDA enforcement record: FDA #Z-1735-2018

Cite this page

“Zimmer Biomet Gentle Threads Interference Screw Recall: Overexposure Risk.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71592-zimmer-biomet-gentle-threads-interference-screw-recall-overexposure-risk. Based on FDA recall #Z-1735-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1735-2018%22&limit=1).

The FDA announced on March 28, 2018, that Zimmer Biomet, Inc. is recalling Gentle Threads and Interference Screws, Model No. 905604, due to potential loss of the sterile barrier from ethylene oxide sterilization overexposure. The recall affects specific lots distributed worldwide.

How to tell if you have it

Brand: Zimmer Biomet
Product: Gentle Threads, Interference Screw
Model No.: 905604
Lot codes: 326860, 326880
Use: Soft tissue reattachment procedures in the ankle/foot and knee
Quantity: 108 units

The hazard

According to the FDA, specific lots of the device were overexposed during ethylene oxide sterilization. This may lead to revision due to infection from loss of sterile barrier during the over-exposure cycle.

Context

GovInfoNow's records show Zimmer Biomet, Inc. has had 94 other recalls since June 5, 2017. Recent brand recalls include a November 20, 2020 spinal rod cutter fracture risk and a November 17, 2020 spinal system screw failure risk. Other recent recalls of similar products include a January 7, 2026 Medline surgical drapes sterility risk and June 9, 2026 Zimmer sterile tourniquet hoses sterility breach risks.

How to tell if you have this one

Check the lot number on the device packaging. Affected lots are 326860 and 326880. The product is used for soft tissue reattachment procedures in the ankle/foot and knee.

Brand
Zimmer Biomet
Category
Medical device

FDA recall event · 6 products

All 6 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, Netherlands, Mexico, Paraguay, Brazil, Argentina, Malaysia, Costa Rica, Chile, South Korea, and Canada.

Recall number	Product, codes & lots	Quantity
Z-1734-2018	Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the ankle/foot and knee.; lot 207910	54
Z-1735-2018	Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and knee.; lot 326860, 326880	108
Z-1736-2018	Gentle Threads, Interference Screw; Model No. 905605, for soft tissue reattachment procedures in the ankle/foot and knee.; lot 326900	53
Z-1737-2018	Gentle Threads, Interference Screw; Model No. 905607, for soft tissue reattachment procedures in the ankle/foot and knee.; lot 326920	54
Z-1738-2018	Gentle Threads, Interference Screw; Model No. 905608, for soft tissue reattachment procedures in the ankle/foot and knee.; lot 326960	54
Z-1739-2018	Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the ankle/foot and knee.; lot 326980, 371540	107

Based on the official FDA remedy

What to do — step by step

Check Device Lot Number
Look for the lot number on the device packaging to determine if it is affected (lots 326860 or 326880).

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution. US nationwide, Netherlands, Mexico, Paraguay, Brazil, Argentina, Malaysia, Costa Rica, Chile, South Korea, and Canada.” 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 12 months after the firm started it.

Mar 28, 2018Firm started the recall
May 8, 2018FDA classified it Class II
May 16, 2018Published in FDA’s Enforcement Report
Mar 29, 2019FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/71592-zimmer-biomet-gentle-threads-interference-screw-recall-overexposure-risk">Zimmer Biomet Gentle Threads Interference Screw Recall: Overexposure Risk (GovInfoNow)</a>

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-1735-2018 (March 28, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1735-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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.