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 Tray Trial, Cat. #321-00-11
Check against the official notice below — it lists the full affected range.
Exactech, Inc. is recalling Humeral Augmented Tray (HAT) trial kits (KIT-321HAT) because the retaining ring in the HAT trial has the potential to disengage during use. The recall affects 36 devices distributed nationwide in Arizona, Colorado, Florida, New York, South Carolina, and Tennessee. The affected products include six different trial types across multiple lot numbers, each with a unique UDI identifier for tracking purposes.
The specific affected lots are: HAT STD Left Tray Trial (Lot #279244001), HAT STD Right Tray Trial (Lot #279244002), HAT LAT Left Tray Trial (Lot #279244017), HAT LAT Right Tray Trial (Lot #279244004), HAT EXT LAT Left Trial (Lot #279244005), and HAT EXT LAT Right Trial (Lot #279244006). The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The HAT trial contains a retaining ring that has shown the potential to disengage during use.
Reason for recall: The HAT trial contains a retaining ring that has shown the potential to disengage during use. Distribution: US Nationwide distribution in the states of AZ, CO, FL, NY, SC, and TN. There was no foreign/government/military distribution. Quantity: 36 devices Lot/code info: (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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.