FDA recall Z-0405-2020

Product

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 3700386944574 DWF605A 3700386944598 DWF605B 3700386944604 DWF605C 3700386944611 DWF606A 3700386944628 DWF606B 3700386944635 DWF606C 3700386944642 DWF607A 3700386944659 DWF607B 3700386944666 DWF607C 3700386944673 DWF608A 3700386944680 DWF608B 3700386944697 DWF608C 3700386944703 DWF609A 3700386944710 DWF609B 3700386944727 DWF609C 3700386944734 DWF611A 3700386944741 DWF611B 3700386944758 DWF611C 3700386944765 DWF612A 3700386944772 DWF612B 3700386944789 DWF612C 3700386944796 DWF613A 3700386944802 DWF613B 3700386944819 DWF613C 3700386944826 DWF614A 3700386944833 DWF614B 3700386944840 DWF614C 3700386944857 DWF615A 3700386944864 DWF615B 3700386944871 DWF615C 3700386944888 DWF6

Reason for recall

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.

Distribution

US Nationwide distribution.

Key facts

Status

Terminated

Initiation date

2019-10-18

Report date

2019-11-20

Termination date

2021-04-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bloomington, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0405-2020