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

Recall Z-0405-2020 — Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 DWF601B 3700386944482 DWF601C 3700386944499 DWF602A 3700386944505 DWF602B 3700386944512 DWF602C 3700386944529 DWF603A 3700386944536 DWF603B 3700386944543 DWF603C 3700386944550 DWF604A 3700386944567 DWF604B 370038694

U.S. FDA — Device Enforcement · United States · 2019-10-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0405-2020
Date of alert
2019-10-18
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Tornier, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
3700386944475
Reported risk: During shipping, it is possible for the Aequalis Ascend Flex humeral stem to become unseated or otherwise move within its internal packaging restraints. Movement within the packaging may cause the product to rub against the PETG blister shipping container causing the transfer of PETG material from the blister container to the stem.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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