The Recall Desk
HighFDA (Devices)·Z-2087-2020·Announced 2020-05-27

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.

What this means for you

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.
Category
Medical Device — Orthopedic Implant
Hazard
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

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 →

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Same manufacturer · Howmedica Osteonics Corp.

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