Zimmer Biomet Recalls Gentle Threads Interference Screws Due to Sterilization Issues
Zimmer Biomet is recalling 107 Gentle Threads interference screws because overexposure to ethylene oxide sterilization may compromise the sterile barrier, potentially leading to infection.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the defect 'may lead to revision due to infection,' which constitutes a significant injury report under the rubric for a Severe (4) classification.
Plain-English summary
Zimmer Biomet, Inc. is recalling 107 units of Gentle Threads, Interference Screw, Model No. 905615. These devices are used for soft tissue reattachment procedures in the ankle, foot, and knee. The recall affects specific lots, identified as 326980 and 371540.
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 FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
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 should check their records for these specific lot numbers. If a patient has received one of these devices, they should contact their healthcare provider to discuss the potential risks and necessary follow-up care.
The recalled product
- Product
- Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the ankle/foot and knee.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 107
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 (2)
- lot 326980
- 371540
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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