# FDA recall Z-0405-2020

> **Tornier, Inc** · Class II · device recall initiated 2019-10-18.

## 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

- **Recall number:** Z-0405-2020
- **Recalling firm:** Tornier, Inc
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0405-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0405-2020. Source: US FDA. Licensed CC0.

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