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 in the inner packaging, resulting in 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 may result in coating debris, which is a low-risk contamination issue without reported injuries.
Plain-English summary
Howmedica Osteonics Corp. is recalling the Stryker Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile. The recall involves 4,895 units distributed worldwide, including in numerous US states.
The recall is being issued 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 present.
Healthcare providers and patients should check their inventory and patient records for the affected catalog number 504-02-64E-R and the specific lot numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to the manufacturer or distributor according to their instructions.
The recalled product
- Product
- Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile, Catalog # 504-02-64E-R, UDI (01)07613327012460(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 HP3142
- J93277
- HK4HK0
- N18T96
- 590V0J
- WA1D8T
- 6D4MT7
- 2V3A9W
- HE19E5
- JN2DWN
- 777N5V
- YY4LXE
- JA0986
- 213804
- 86112L
- 8X4H1D
- N25J45
- EM8Y25
- 647TEX
- J011V3
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.
See all 16 products in this recall →Related recalls
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