Class II U.S. Food and Drug Administration

Exactech Equinoxe recall: Reverse Shoulder humeral liners have an articular surface position outside

Recall published 1+ years ago

Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2561-2025
Published
September 24, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Exactech, Inc.
Product type
Medical devices
Units affected
61,334 UNITS
Distribution
Nationwide
Made in
United States
Lot / code info
All Serial Numbers, REF: 320-38-00/UDI:10885862086655 REF: 320-38-03/UDI: 10885862086662 REF: 320-42-00/UDI: 10885862086693 REF: 320-42-03/UDI: 10885862086709
UPC codes
10885862086655, 10885862086662, 10885862086693, 10885862086709

Products covered by this recall

Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/

Check your product

The notice names 10 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10885862086655
  • 10885862086662
  • 10885862086693
  • 10885862086709

Model or item number

On the rating label, the box or the instruction sheet.

  • 320-38-00
  • UDI
  • 320-38-03
  • 320-42-00
  • 320-42-03

Serial number

On the rating plate, often next to the date of manufacture.

  • REF

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Exactech, Inc. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Exactech, Inc. — 2320 Nw 66th Ct, Gainesville, FL, 32653-1630

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Exactech, Inc. medical devices recalled?

Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling. Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10885862086655, 10885862086662, 10885862086693; model number 320-38-00, UDI, 320-38-03. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls