Reported Nov 20, 2019 · Terminated

Aequalis Ascend Flex Humeral Stem

Tornier, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Tornier, Inc · 10801 Nesbitt Ave S · Bloomington, MN · 55437-3109

Is this the product you have?

Aequalis Ascend Flex Humeral Stem

101 of 101 products

Products covered by this recall
Model / numberProduct as published
3700386944475DWF601A
3700386944482DWF601B
3700386944499DWF601C
3700386944505DWF602A
3700386944512DWF602B
3700386944529DWF602C
3700386944536DWF603A
3700386944543DWF603B
3700386944550DWF603C
3700386944567DWF604A
3700386944574DWF604B
3700386944598DWF605A
3700386944604DWF605B
3700386944611DWF605C
3700386944628DWF606A
3700386944635DWF606B
3700386944642DWF606C
3700386944659DWF607A
3700386944666DWF607B
3700386944673DWF607C
Lot codes and dates
  • All Lot/Serial Numbers
Amount recalled
87869 units

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Tornier, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 9, 2021 · Data as of Sep 19, 5:28 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.