Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2088-2020·Announced 2020-05-27

Stryker Restoration Anatomic Shell Recalled for Packaging Defect

Howmedica Osteonics is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post within the inner packaging, resulting in loose 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, which typically corresponds to a Moderate severity score when no specific injuries or hospitalizations are reported in the source text. The hazard is a packaging defect leading to potential debris, which is a lower risk than structural failure or contamination.

Plain-English summary

Howmedica Osteonics Corp. is recalling 4,895 units of the Stryker Restoration Anatomic Hemispherical Shell, Size 56 Right, Sterile (Catalog # 504-02-56D-R). The recall affects specific lot numbers, including EE5WWV, DY6V66, and 4T75EE, among others. The devices were distributed worldwide, including in numerous U.S. states such as New York, Texas, and California.

The recall was initiated because the Stryker Restoration Anatomic Shell 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 FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and facilities that have received these devices should stop using them and contact Howmedica Osteonics Corp. for instructions on return or replacement. Patients who have had these devices implanted should contact their healthcare provider to discuss the recall and any necessary follow-up care.

The recalled product

Product: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right, Sterile, Catalog # 504-02-56D-R, UDI (01)07613327012347(17)
Manufacturer: Howmedica Osteonics Corp.
Category: Medical Device — Orthopedic Implant
Hazard: packaging-defect
debris
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 EE5WWV
DY6V66
4T75EE
HT3X47
YX8KLL
99554T
T58TR0
A46AJA
P23W2H
9X0WHV
681E6V
XP0AKD
RD53PW
R67PR4
N11PLW
WW20KE
KV6P9X
6X4R9T
2X4KLD
M08065

Distribution

Distributed in 30 states:

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 →

Same manufacturer · Howmedica Osteonics Corp.

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Same hazard · packaging defect