Stryker Restoration Anatomic Shell Recall Due to Packaging Defect
Howmedica Osteonics is recalling Stryker Restoration Anatomic Shells because the device may fall off its post within the inner packaging, resulting in loose components and coating debris.
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 a packaging defect that could lead to device contamination or loss, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Howmedica Osteonics Corp. is recalling Stryker Orthopaedics Restoration Anatomic Hemispherical Shells, Size 66 right, sterile. The recall involves 4,895 units distributed worldwide, including numerous U.S. states. The specific catalog number is 504-02-66F-R.
The recall was initiated because the device may fall off its post within its inner packaging. This defect can result in the device being loose in the package with coating debris. The source text does not report any illnesses, injuries, or deaths associated with this defect.
Healthcare providers and facilities should stop using the affected devices and contact Howmedica Osteonics Corp. for instructions on return or replacement. The recall covers specific lot numbers listed in the agency's official documentation.
The recalled product
- Product
- Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 right, Sterile, Catalog # 504-02-66F-R, UDI (01)07613327012477(17)
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 4,895
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 (20)
- Lot #s 1X5DJK
- NH4W8Y
- 744EH9
- AD25RA
- 7E4HW3
- 1N21NK
- E00T60
- WY1DD1
- D26R36
- H74H7L
- RT0AK2
- 593Y5R
- AD00T8
- E12H25
- 9K66L6
- AL7K8E
- MP11MY
- D04T4A
- 8K74RX
- 1R57DY
Distribution
Part of a larger recall action
This product is one of 16 recalled by 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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