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

Recall Z-1690-2019 — Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90

U.S. FDA — Device Enforcement · United States · 2019-04-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1690-2019
Date of alert
2019-04-26
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Exactech, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10885862094100
Reported risk: The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.
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.

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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.