Agency classClass IIOur severity:Severe FDA (Devices)·Z-0144-2018·Announced 2017-11-29

Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

Exactech is recalling 317 Optetrak Offset Tibial Trays because a design incompatibility exists with certain offset spine stiffener screws and constrained condylar tibial inserts.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are mapped to a severity score of 4 (Severe), particularly when involving structural or design defects in medical devices that could lead to significant injury.

Plain-English summary

Exactech, Inc. is recalling 317 units of the Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Alpha, Ref 208-04-53. The devices are sterile and require a prescription. The recall covers all lot numbers of this specific product configuration.

The recall is due to a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with the offset tibial tray. This is a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.

Distribution of the affected devices was made to Alabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Virginia, and Puerto Rico. Foreign distribution included Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and the United Kingdom. Healthcare providers should contact Exactech for further instructions on handling the recalled devices.

The recalled product

Product: Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Alpha, Ref 208-04-53, Sterile, RX.
Manufacturer: Exactech, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: design-incompatibility
structural-defect
Affected units: 317

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)

All lot numbers

Distribution

Distributed in 11 states:

Part of a larger recall action

This product is one of 34 recalled by Exactech, 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 34 products in this recall →

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