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

Recall Z-0349-2020 — MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T-Handle Trial Spacer 11mm with T-Handle Trial Spacer 12mm with T-Handle Trial Spacer 13mm with T-Handle Trial Spacer 15mm with T-Handle Trial Spacer 17m

U.S. FDA — Device Enforcement · United States · 2019-09-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0349-2020
Date of alert
2019-09-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Synthes (USA) Products LLC
Product category
device
Product type
Devices
Reported risk: Modified outside of approved manufacturing process
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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