PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported November 20, 2019

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 37

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 packa…

Recall #
Z-0405-2020
Affected scope
87869 units
Initiated
October 18, 2019
Compiled from official public sources by the publisher.
Verify with FDA Devices →
View my saved recalls

Tornier, Inc recalled Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 DWF601B 37003… - a moderate-severity action.

Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 DWF601B 37003… was recalled by Tornier, Inc in November 20, 2019. Reason: During shipping, it is possible for the Aequalis Ascend Flex humeral stem to become unseated or otherwise mov…. Check the official notice for the remedy. Verify recall #Z-0405-2020 with the FDA Devices before acting.

The recall

Tornier, Inc issued this moderate-severity FDA Devices recall-During shipping, it is possible for the Aequalis Ascend Flex humeral stem to become unseated or otherwise mov….

Moderate
severity level
88K units
affected scope
Class II
classification
November 20, 2019
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0405-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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 DWF616A 3700386944895 DWF616B 3700386944901 DWF616C 3700386944918 DWF617A 3700386944925 DWF617B 3700386944932 DWF617C 3700386944949 DWF618A 3700386944956 DWF618B 3700386944963 DWF618C 3700386944970 DWF619A 3700386944987 DWF619B 3700386944994 DWF619C 3700386945007 DWF702A 3700386945045 DWF702B 3700386945052 DWF702C 3700386945069 DWF703A 3700386945076 DWF703B 3700386945083 DWF703C 3700386945090 DWF704A 3700386945106 DWF704B 3700386945113 DWF704C 3700386945120 DWF705A 3700386945137 DWF705B 3700386945144 DWF705C 3700386945151 DWF706A 3700386945168 DWF706B 3700386945175 DWF706C 3700386945182 DWF707A 3700386945199 DWF707B 3700386945205 DWF707C 3700386945212 DWF708A 3700386945229 DWF708B 3700386945236 DWF708C 3700386945243 DWF709A 3700386945250 DWF709B 3700386945267 DWF709C 3700386945274 DWF712A 3700386945311 DWF712B 3700386945328 DWF712C 3700386945335 DWF713A 3700386945342 DWF713B 3700386945359 DWF713C 3700386945366 DWF714A 3700386945373 DWF714B 3700386945380 DWF714C 3700386945397 DWF715A 3700386945403 DWF715B 3700386945410 DWF715C 3700386945427 DWF716A 3700386945434 DWF716B 3700386945441 DWF716C 3700386945458 DWF717A 3700386945465 DWF717B 3700386945472 DWF717C 3700386945489 DWF718A 3700386945496 DWF718B 3700386945502 DWF718C 3700386945519 DWF719A 3700386945526 DWF719B 3700386945533 DWF719C 3700386945540 Product Usage: The AEQUALIS ASCEND FLEX Convertible Shoulder System is intended for use as: A replacement of shoulder joints in primary anatomic or primary reverse. A replacement of other shoulder joint devices in case of revisions, if sufficient bone stock remains. The AEQUALIS ASCEND FLEX Convertible Shoulder System also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-0405-2020
Date reported November 20, 2019
Date initiated October 18, 2019
Recalling firm Tornier, Inc
Firm location Bloomington, MN
Affected scope 87869 units
Distribution US Nationwide distribution.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

87869 units units affected - limited or regional distribution scale.

Regional (<10K units) -
Multi-state (10K – 100K units) ✓ This recall
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-0405-2020) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼
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 DWF616A 3700386944895 DWF616B 3700386944901 DWF616C 3700386944918 DWF617A 3700386944925 DWF617B 3700386944932 DWF617C 3700386944949 DWF618A 3700386944956 DWF618B 3700386944963 DWF618C 3700386944970 DWF619A 3700386944987 DWF619B 3700386944994 DWF619C 3700386945007 DWF702A 3700386945045 DWF702B 3700386945052 DWF702C 3700386945069 DWF703A 3700386945076 DWF703B 3700386945083 DWF703C 3700386945090 DWF704A 3700386945106 DWF704B 3700386945113 DWF704C 3700386945120 DWF705A 3700386945137 DWF705B 3700386945144 DWF705C 3700386945151 DWF706A 3700386945168 DWF706B 3700386945175 DWF706C 3700386945182 DWF707A 3700386945199 DWF707B 3700386945205 DWF707C 3700386945212 DWF708A 3700386945229 DWF708B 3700386945236 DWF708C 3700386945243 DWF709A 3700386945250 DWF709B 3700386945267 DWF709C 3700386945274 DWF712A 3700386945311 DWF712B 3700386945328 DWF712C 3700386945335 DWF713A 3700386945342 DWF713B 3700386945359 DWF713C 3700386945366 DWF714A 3700386945373 DWF714B 3700386945380 DWF714C 3700386945397 DWF715A 3700386945403 DWF715B 3700386945410 DWF715C 3700386945427 DWF716A 3700386945434 DWF716B 3700386945441 DWF716C 3700386945458 DWF717A 3700386945465 DWF717B 3700386945472 DWF717C 3700386945489 DWF718A 3700386945496 DWF718B 3700386945502 DWF718C 3700386945519 DWF719A 3700386945526 DWF719B 3700386945533 DWF719C 3700386945540 Product Usage: The AEQUALIS ASCEND FLEX Convertible Shoulder System is intended for use as: A replacement of shoulder joints in primary anatomic or primary reverse. A replacement of other shoulder joint devices in case of revisions, if sufficient bone stock remains. The AEQUALIS ASCEND FLEX Convertible Shoulder System also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.. Recalled by Tornier, Inc. Units affected: 87869 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 20, 2019. Severity: Moderate. Recall number: Z-0405-2020.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution..
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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This recall: FDA Devices, reported November 20, 2019. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026