Zimmer Biomet Gentle Threads Interference Screw Recall: Overexposure Risk

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

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.

Why it’s dangerous

The device may have been overexposed during EtO sterilization, which can compromise the sterile barrier and lead to infection. This risk occurs if the device is used without proper sterilization.

Who’s affected

Patients who received the specific lots (326860, 326880) of Gentle Threads Interference Screw (Model 905604) for ankle/foot or knee procedures are most at risk. Healthcare providers using the device are also affected.

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

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).

✎ GovInfoNow

Questions people ask

What is the specific model number of the recalled device?

The recalled device is Gentle Threads Interference Screw, Model No. 905604.

Which lots of the device are affected?

Lots 326860 and 326880 are affected.

What is the hazard with the recalled device?

Overexposure during EtO sterilization may lead to infection due to loss of the sterile barrier.

Take action

Contact Zimmer Biomet

We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1735-2018 — Zimmer Biomet Zimmer Biomet

Hello,

I own a Zimmer Biomet that is covered by recall Z-1735-2018 from Zimmer Biomet.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-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.

Zimmer Biomet, Inc. recalls Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and

Lower-risk recall