Tornier Recalls Aequalis Ascend Flex Humeral Stems Due to Packaging Material Transfer
Tornier, Inc. is recalling 87,869 Aequalis Ascend Flex Humeral Stems because movement during shipping may cause PETG material from the packaging to transfer to the device.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential material transfer from packaging, which is a low-risk contamination issue without reported injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Tornier, Inc. is recalling 87,869 units of the Aequalis Ascend Flex Humeral Stem, a medical device intended for shoulder joint replacement. The recall covers all lot and serial numbers and involves nationwide distribution in the United States.
The recall was initiated because the humeral stem may become unseated or move within its internal packaging restraints during shipping. This movement can cause the product to rub against the PETG blister shipping container, resulting in the transfer of PETG material from the container to the stem.
Consumers and healthcare providers should contact Tornier, Inc. for instructions on how to proceed with the recall. The source text does not specify a date for the recall or report any illnesses or injuries associated with this issue.
The recalled product
- 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 370038694456
- Manufacturer
- Tornier, Inc
- Affected units
- 87,869
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lot/Serial Numbers
Distribution
Distributed nationwide across the United States.
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