Zimmer Biomet Recalls Gentle Threads Interference Screws Due to Sterilization Issue
Zimmer Biomet is recalling 54 Gentle Threads interference screws because overexposure to ethylene oxide sterilization may compromise the sterile barrier, potentially leading to infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II. The hazard involves a potential loss of sterile barrier leading to infection, which is a risk-of-harm scenario where injury has not yet been explicitly reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Zimmer Biomet, Inc. is recalling 54 units of the Gentle Threads, Interference Screw (Model No. 905608). This medical device is used for soft tissue reattachment procedures in the ankle, foot, and knee. The specific lot affected is 326960.
The recall was initiated because specific lots of the device were overexposed during the ethylene oxide (EtO) sterilization process. 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 should contact Zimmer Biomet for further instructions regarding the recall and potential replacement or removal of the device.
The recalled product
- Product
- Gentle Threads, Interference Screw; Model No. 905608, 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 326960
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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