Agency classClass IIOur severity:High FDA (Devices)·Z-1977-2021·Announced 2021-07-07

Exactech Humeral Augmented Tray orthopedic implant components recalled for disengagement risk

Exactech is recalling Humeral Augmented Tray (HAT) orthopedic implant components because the retaining ring may disengage during use. The recall affects 36 devices distributed in six U.S. states.

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: This is an FDA Class II recall of a medical device component with potential to fail during use. No injuries or deaths have been reported; the hazard is theoretical, so per the rubric this qualifies as High (3) rather than Severe.

Plain-English summary

Exactech, Inc. is recalling Humeral Augmented Tray (HAT) trial components used with the Equinoxe Reverse Shoulder System orthopedic implant. Each kit contains six trial components in different configurations.

The retaining ring in the HAT trials has shown potential to disengage during use. An unexpected disengagement could affect the function of these trial components.

The recall affects 36 devices distributed across Arizona, Colorado, Florida, New York, South Carolina, and Tennessee. The affected devices span six different product configurations, each with distinct lot numbers.

The recalled product

Product: Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat. #321-00-01; (2) HAT STD Right Tray Trial, Cat. #321-00-02; (3) HAT LAT Left…
Manufacturer: Exactech, Inc.
Category: Medical Device — Orthopedic Implant Component
Hazard: disengagement
component-failure
Affected units: 36

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 (18)

(1) HAT STD Left Tray Trial
Lot #279244001
UDI 10885862541239
(2) HAT STD Right Tray Trial
Lot #279244002
UDI 10885862541246
(3) HAT LAT Left Tray Trial
Lot #279244017
UDI 10885862541253
(4) HAT LAT Right Tray Trial
Lot #279244004
UDI 10885862541260
(5) HAT EXT LAT Left Trial
Lot #279244005
UDI 10885862541277
and (6) HAT EXT LAT Right Trial
Lot #279244006
UDI 10885862541284.

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Same manufacturer · Exactech, Inc.

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Same hazard · disengagement