Agency classClass IIOur severity:High FDA (Devices)·Z-1736-2018·Announced 2018-05-16

Zimmer Biomet Recalls Gentle Threads Interference Screws Due to Sterilization Issues

Zimmer Biomet is recalling 53 Gentle Threads Interference Screws because overexposure to ethylene oxide sterilization may have compromised 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 involves a risk of harm (infection) from a compromised sterile barrier, but the source text does not report any actual illnesses or injuries, fitting the criteria for a High severity score.

Plain-English summary

Zimmer Biomet, Inc. is recalling 53 units of the Gentle Threads, Interference Screw (Model No. 905605). These devices are used for soft tissue reattachment procedures in the ankle, foot, and knee. The recall involves lot 326900, which was 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 specific lots of the device were overexposed during the ethylene oxide (EtO) sterilization process. This overexposure may have caused a loss of the sterile barrier, which could lead to infection and the need for revision surgery.

Healthcare providers and patients who have used or are scheduled to use this specific lot of the device should contact Zimmer Biomet for further instructions. 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. 905605, 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: 53

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 326900

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