Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect
Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Shell devices because they may fall off their posts within the inner packaging, resulting in loose devices and coating debris.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, and the hazard involves a packaging defect that results in a loose device and debris. No injuries or illnesses are reported in the source text, and the defect is primarily a quality control issue rather than a direct biological or structural failure of the implanted device itself.
Plain-English summary
Howmedica Osteonics Corp. is recalling the Stryker Restoration Anatomic Shell (RAS), a sterile orthopedic device. The recall involves 4,895 units of the Size 62 left shell, Catalog # 504-02-62E-L. The devices are distributed worldwide, including in numerous U.S. states such as New York, Texas, California, and Florida.
The recall is being issued because the Stryker Restoration Anatomic Shell may fall off its post within the inner packaging. This defect can result in the device being loose in the package and the presence of coating debris. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.
Healthcare providers and facilities that have received these devices should stop using them and contact Howmedica Osteonics Corp. for instructions on how to return or dispose of the affected units. The recall covers specific lot numbers, which are listed in the official FDA documentation.
The recalled product
- Product
- Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 left, Sterile, Catalog # 504-02-62E-L, UDI (01)07613327012453(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 EK2JXE
- V26EXD
- K97J79
- MV20HR
- RM5RX2
- 478E97
- ET7EXW
- J74RKR
- L71A2P
- P276D0
- M15D1R
- ND74JJ
- 6P6MWY
- X500MV
- K931PP
- 6J36RW
- MH415K
- T96X19
- VM332V
- WW65Y5
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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