Reported Jul 7, 2021 · Completed
Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following…
Exactech, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Exactech, Inc. · 2320 Nw 66th Ct · Gainesville, FL · 32653-1630
Is this the product you have?
6 of 6 products
| Model / number | Product as published |
|---|---|
321-00-01 | 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 |
321-00-02 | (2) HAT STD Right Tray Trial |
321-00-11 | (3) HAT LAT Left Tray Trial |
321-00-12 | (4) HAT LAT Right Tray Trial |
321-00-21 | (5) HAT EXT LAT Left Trial |
321-00-22. | and (6) HAT EXT LAT Right Trial, The Humeral Augmented Tray is designed to function with the Equinoxe Reverse Shoulder System orthopedic implant components. |
- Lot codes and dates
6 of 6 products
Products covered by this recall # Barcodes Product as published 1 10885862541239(1) HAT STD Left Tray Trial, Lot #279244001, UDI 10885862541239 2 10885862541246(2) HAT STD Right Tray Trial, Lot #279244002, UDI 10885862541246 3 10885862541253(3) HAT LAT Left Tray Trial, Lot #279244017, UDI 10885862541253 4 10885862541260(4) HAT LAT Right Tray Trial, Lot #279244004, UDI 10885862541260 5 10885862541277(5) HAT EXT LAT Left Trial, Lot #279244005, UDI 10885862541277 6 10885862541284and (6) HAT EXT LAT Right Trial, Lot #279244006, UDI 10885862541284. - Amount recalled
- 36 devices
Where it was sold
Why it was recalled
The HAT trial contains a retaining ring that has shown the potential to disengage during use.
This product could cause temporary or reversible health problems — stop using it.
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