Stryker Restoration Anatomic Shell Recalled 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.
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 could lead to device contamination or damage, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Howmedica Osteonics Corp. is recalling Stryker Orthopaedics Restoration Anatomic Hemispherical Shells, Size 64 left, sterile. The recall involves specific catalog and UDI numbers, as well as a list of 45 specific lot numbers.
The recall is being issued 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 product was distributed worldwide, including in numerous US states such as New York, Texas, California, and Florida.
Healthcare providers and facilities that have received these devices should stop using them and contact Howmedica Osteonics Corp. for further instructions on the recall process.
The recalled product
- Product
- Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, Sterile, Catalog # 504-02-64E-L, UDI (01)07613327012484(17)
- Manufacturer
- Howmedica Osteonics Corp.
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 Y32LP9
- AN6ATN
- A77J57
- EE69A8
- 625VEM
- K8549T
- EV6MXD
- L85MMA
- 7E2R48
- M21Y21
- H71N5N
- A74YXL
- PN2X3H
- V2774X
- AE6LJR
- 7D0YJE
- 6957YA
- LM5N9M
- 477ELH
- JN8347
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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