Agency classClass IIOur severity:High FDA (Devices)·Z-1735-2018·Announced 2018-05-16

Zimmer Biomet Recalls Gentle Threads Interference Screws Due to Sterilization Issues

Zimmer Biomet is recalling specific lots of Gentle Threads Interference Screws because they were overexposed to ethylene oxide sterilization, which may compromise the sterile barrier.

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 involves a risk of infection due to a compromised sterile barrier, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Zimmer Biomet, Inc. is recalling 108 units of Gentle Threads, Interference Screw, Model No. 905604. These devices are used for soft tissue reattachment procedures in the ankle, foot, and knee. The recall affects specific lots (326860 and 326880) that were distributed worldwide, including in the United States, Canada, Mexico, Brazil, Argentina, Chile, Costa Rica, Malaysia, South Korea, Paraguay, and the Netherlands.

The recall was initiated because the 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.

Healthcare providers and patients who have received these specific devices should contact Zimmer Biomet for further instructions on how to proceed. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product: Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and knee.
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: infection
sterilization-failure
Affected units: 108

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 326860
326880

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.

See all 6 products in this recall →

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · infection