Stryker Restoration Anatomic Shell Recalled for Packaging Defect
Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Shell devices because they may fall off their post within the inner packaging, resulting in loose devices 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, but the source text describes a packaging defect without reporting any illnesses, injuries, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Howmedica Osteonics Corp. is recalling Stryker Orthopaedics Restoration Anatomic Hemispherical Shell devices, Size 54 Right, Sterile, Catalog # 504-02-54C-R. The recall involves 4,895 units distributed worldwide, including in numerous U.S. states.
The recall is being conducted because the Stryker Restoration Anatomic Shell (RAS) 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 specific illnesses, injuries, or deaths associated with this defect.
Healthcare providers and patients who have received these specific devices should contact Howmedica Osteonics Corp. for further instructions on how to proceed. The recall covers specific lot numbers listed in the agency's official documentation.
The recalled product
- Product
- Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right, Sterile, Catalog # 504-02-54C-R, UDI (01)07613327012415(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 6A7N7Y
- J50WR6
- EM4ED2
- 4908KM
- K14HL3
- VN5NTY
- 4X7XE4
- JK4A37
- W20A86
- EM5Y28
- H81JNL
- EE883L
- 9L8LMD
- 7Y2HM0
- MM0JYY
- K23J10
- DY42DE
- 3P3P64
- H77Y5E
- MX801E
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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