Equinoxe recallZ-0958-2019 · Exactech, Inc. · initiated Dec 5, 2018

Why it was recalled

Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently packaged with an Optetrak Knee System instructions for use (IFU) rather than the Equinoxe Preserve Humeral Stem IFU as intended .

FDA root cause category: Packaging

What the company is doing

On about 12/05/2018, Exactech notified customers via "URGENT MEDICAL DEVICE RECALL" notification sent through email. Instructions included to immediately cease distribution or use of affected products, provide the recall information to customers if further distributed, identify and quarantine any affected devices in inventory, complete and return the Recall Acknowledgement Form, and make arrangements to return affected devices to Exactech.

Recall details

Recall number

Z-0958-2019

Status

Terminated

Initiated by the company

Dec 5, 2018

Recalling firm

Exactech, Inc.

Quantity

40 devices

Product code

PHX

FDA submissions

K162726

Distribution

US Nationwide distribution in the states of AL,FL, IA, LA, MD, OH, SC.

Product description

Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total arthroplasty,anatomic hemi-arthroplasty,or reverse total arthroplasty is determined by the surgeon to be the preferred method of treatment. The Equinoxe Preserve Stems are additionally indicated for use in reverse total arthroplasty in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff or a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Equinoxe Preserve Stems are intended for press-fit applications but may be used with bone cement at the discretion of the surgeon.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Equinoxe 300-30-08

  Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 recall11 reports

Product lines

• EquinoxeExactech, Inc. · 305 models · 2,076 reports · 37 recalls

Other devices under the same FDA submission

10 devices cleared under K162726 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• Equinoxe 300-30-06

  Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  28 reports
• Equinoxe 300-30-10

  Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  8 reports
• Equinoxe 300-30-07

  Exactech, Inc. · Shoulder Prosthesis, Reverse Configuration
  5 reports
• Equinoxe 300-30-09

  Exactech, Inc. · Shoulder Prosthesis, Reverse Configuration
  3 reports
• Equinoxe 300-30-12

  Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  3 reports
• Equinoxe 300-30-11

  Exactech, Inc. · Shoulder Prosthesis, Reverse Configuration
  2 reports
• Equinoxe 300-30-14

  Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  2 reports
• Equinoxe 300-30-13

  Exactech, Inc. · Shoulder Prosthesis, Reverse Configuration
  1 report
• Equinoxe 300-30-15

  Exactech, Inc. · Shoulder Prosthesis, Reverse Configuration
  1 report
• Equinoxe 321-05-21

  Exactech, Inc. · PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report