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

Recall Z-0873-2020 — Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, REF 304-22-11 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint work total or hemi- arthroplasty is dete

U.S. FDA — Device Enforcement · United States · 2019-12-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0873-2020
Date of alert: 2019-12-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Exactech, Inc.
Product category: device
Product type: Devices

Reported risk: Labels with incorrect translations were identified by Exactech is a distributor in the Netherlands. The translations on the outer labels include the word " long" in all languages other than the original English version. The implants are standard length fracture stems.

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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