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 s
Check against the official notice below — it lists the full affected range.
Exactech, Inc. is recalling 40 units of the Equinoxe Preserve Humeral Stem, 8mm, a shoulder implant used in patients with degenerative joint disease. The recall was issued because these devices were inadvertently packaged with instructions for use for an Optetrak Knee System instead of the correct instructions for the Equinoxe Preserve Humeral Stem. The affected devices were distributed nationwide to Alabama, Florida, Iowa, Louisiana, Maryland, Ohio, and South Carolina.
The recalled devices have catalog number 300-30-08 and UDI 10885862515766, with the following serial numbers: 5569566, 5569576, 5569579, 5569582, 5569584, 5569586, 5569589, and 5569595. The source document does not specify a remedy or any action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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 .
Reason for recall: 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 . Distribution: US Nationwide distribution in the states of AL,FL, IA, LA, MD, OH, SC. Quantity: 40 devices Lot/code info: Catalog Number: 300-30-08; UDI: 10885862515766; Serial Numbers: 5569566, 5569576, 5569579, 5569582, 5569584, 5569586, 5569589, 5569595.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.