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.
Plain-English summary
Howmedica Osteonics Corp. is recalling Stryker Orthopaedics Restoration Anatomic Hemispherical Shells, Size 58 Left, Sterile, Catalog # 504-02-58D-L. The recall involves 4,895 units distributed worldwide, including in numerous U.S. states.
The recall is being conducted 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. The agency has classified this as a Class II recall.
Healthcare providers and facilities should stop using the affected devices and contact the recalling firm for instructions on return or replacement. Consumers should not use the product if they have it in their possession.
The recalled product
- Product
- Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07613327012385(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 AX3V4E
- DX109D
- TD2X0H
- JV415X
- KW5467
- HM4L3L
- WK5WV2
- LD2HHY
- A67ERK
- Y579RW
- RW1XVW
- VJ7TE0
- M02DYJ
- EW1TJ5
- 371T2M
- 2W3T75
- 345TJ9
- N968R7
- H386RY
- 978TAX
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
Same manufacturer · Howmedica Osteonics Corp.
See all →- SevereHowmedica Recalls Scorpio Patella Implants Due to Polyethylene Wear Risk
FDA (Devices) · 2026-09-23
- HighHowmedica Recalls Orthopaedic Implants Due to Potential UHMWPE Oxidation
FDA (Devices) · 2026-09-23
- SevereHowmedica Recalls Orthopaedic Implants Due to Potential UHMWPE Oxidation
FDA (Devices) · 2026-09-23
- HighHowmedica Recalls Orthopaedic Implant Components Due to Material Aging
FDA (Devices) · 2026-09-23
- HighHowmedica Recalls Scorpio Receded Metal Backed Patella Implants
FDA (Devices) · 2026-09-23
Same hazard · packaging defect
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- ModerateStryker Howmedica Hip Prosthesis Components Recalled for Seal Defects
FDA (Devices) · 2015-05-27
- ModerateStryker Triathlon Femoral Component Recalled for Sterile Barrier Seal Issues
FDA (Devices) · 2015-05-27
- ModerateStryker Recalls rHead and uHead Implants Due to Packaging Integrity Concerns
FDA (Devices) · 2015-08-26
- ModerateStryker T2 Fixation K-Wire Recall Due to Packaging Seal Integrity Concerns
FDA (Devices) · 2016-03-02
- ModerateStryker Triathlon Femoral Distal Augment Recalled for Packaging Label Errors
FDA (Devices) · 2013-05-29
- ModerateStryker Gamma3 K-Wire Recall Due to Potential Packaging Seal Integrity Issues
FDA (Devices) · 2016-03-02