Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0958-2019 — 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 t

U.S. FDA — Device Enforcement · United States · 2018-12-05 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0958-2019
Date of alert: 2018-12-05
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Exactech, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10885862515766

Reported risk: 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 .

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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