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

Recall Z-2251-2021 — Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.

U.S. FDA — Device Enforcement · United States · 2021-06-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2251-2021
Date of alert
2021-06-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Exactech, Inc.
Product category
device
Product type
Devices
Reported risk: Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5).
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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