Tornier, Inc 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 37
Brand
Tornier, Inc
Lot Codes / Batch Numbers
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Products Sold
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Tornier, Inc is recalling Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 DWF601B 3700386944482 D due to During shipping, it is possible for the Aequalis Ascend Flex humeral stem to become unseated or otherwise move within its internal packaging restraint. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The firm notified their consignees by letter on 10/18/2019. The notices explained the issue and requested the following: Please undertake the following urgent actions when using Aequalis Ascend Flex humeral stems: " Ensure backup stem product is available in the operating room or is easily accessible prior to beginning surgery. " Visually examine the stem after removing the stem from its packaging. " If white film or particles are seen on the stem as pictured in Attachment A, immediately remove the implant and anything it touches from the sterile field. Replace the stem with a backup stem that lacks visible white film or particles. " If no packaging material is visible on the stem, you may proceed with the implantation procedure. " Report the discovery of any stems with packaging material to Wright Medical. " Contact customer service to facilitate the return and replacement of any affected product o Customer Service Customer.service@Wright.com, or 1-888-494-7950 o Return product to Wright Medical, 10801 Nesbitt Ave S, Bloomington, MN 55437 o Please identify that this product and issue is related to Field Action FA-WMG-2019-005 Please contact the following for information: Customer service Customer.service@Wright.com (replacements, product support) Field Action Team FieldAction@Wright.com (more information on this notice) Complaints Team Complaints-US@Wright.com (If product is found to be non-conforming)
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026