Stryker Recalls Sigmoid Notch Radial Plates Due to Packaging Integrity Concerns
Stryker is recalling Sigmoid Notch Radial Plates because the sterile packaging barrier may be compromised during transportation.
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, but the source text describes a potential packaging integrity issue without reporting any specific illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling Sigmoid Notch Radial Plates, specifically the Small and Large sterile versions. These medical devices are intended for the replacement of the distal radio-ulnar joint following ulnar head resection arthroplasty.
The recall was initiated because the integrity of the sterile barrier for the KIT I packaging type may potentially be compromised by transportation. This issue could affect the sterility of the devices.
The recall involves 16,992 total units distributed worldwide. Affected products include Part Number 390-0305 (Sigmoid Notch Radial Stem, Small) with Lot #s 18362, 22834401, and 23852901, and Part Number 390-0307 (Sigmoid Notch Radial Stem, Large) with Lot #s 18728, 18815, 18816, 18817, 23834501, and 23853001. Healthcare providers should stop using these specific lots and contact Stryker for further instructions.
The recalled product
- Product
- Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the distal radio-ulnar joint following ulnar head resection arthroplasty.
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 16,992
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 (9)
- Part Number: 390-0305 (Sigmoid Notch Radial Stem
- Small) - Lot #'s 18362
- 22834401 and 23852901
- Part Number: 390-0307 (Sigmoid Notch Radial Stem
- Large) - Lot #'s 18728
- 18815
- 18816
- 18817
- 23834501 and 23853001
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Stryker Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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