Zimmer Biomet Recalls Gentle Threads Interference Screws Due to Sterilization Error
Zimmer Biomet is recalling 54 Gentle Threads Interference Screws because overexposure to ethylene oxide sterilization may compromise the sterile barrier, increasing infection risk.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of harm (infection) from a loss of sterile barrier, but the source text does not report any actual illnesses or injuries, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 54 units of the Gentle Threads Interference Screw, Model No. 905607, used for soft tissue reattachment procedures in the ankle, foot, and knee. The recall is limited to lot 326920.
The recall was initiated because specific lots of the device were overexposed during ethylene oxide (EtO) sterilization. This overexposure may lead to a loss of the sterile barrier, which could result in infection and the need for revision surgery.
The affected devices were distributed worldwide, including in the United States, Netherlands, Mexico, Paraguay, Brazil, Argentina, Malaysia, Costa Rica, Chile, South Korea, and Canada. Healthcare providers and patients who have received this specific device should contact Zimmer Biomet or their healthcare provider for further instructions.
The recalled product
- Product
- Gentle Threads, Interference Screw; Model No. 905607, for soft tissue reattachment procedures in the ankle/foot and knee.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 54
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- lot 326920
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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