Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect
Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post within 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (loose device and coating debris) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Howmedica Osteonics Corp. is recalling Stryker Orthopaedics Restoration Anatomic Hemispherical Shells, Size 60 Left, Sterile. The recall involves 4,895 units distributed worldwide, including in numerous U.S. states. The specific product is identified by Catalog # 504-02-60D-L and UDI (01)07613327012422(17).
The recall is being conducted 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 agency has classified this as a Class II recall.
Healthcare providers and facilities should check their inventory for the affected lot numbers and stop using the product if it matches the description. Patients who have had this device implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, Sterile, Catalog # 504-02-60D-L, UDI (01)07613327012422(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 Y461NK
- 916M1K
- 3581JK
- 306XWX
- AH4AER
- YP48JA
- 6J7PTL
- KT81WD
- 1D6NNE
- 467JP5
- 6M025E
- T4286L
- 633D81
- 6L6ADX
- N175H8
- WJ41VD
- RM697T
- A602M0
- 840Y1A
- 988KM2
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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