The Recall Desk
ModerateFDA (Devices)·Z-2099-2020·Announced 2020-05-27

Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect

Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Shell devices because they may fall off their post in packaging, resulting in loose devices with coating debris.

What this means for you

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, but the source text describes a packaging defect (device falling off post) without reporting any injuries, illnesses, or deaths. Per the rubric, this aligns with a moderate severity score for a defect where harm has not been reported.

Plain-English summary

Howmedica Osteonics Corp. is recalling the Stryker Restoration Anatomic Shell (RAS), a sterile orthopedic device. The recall involves 4,895 units of the Size 68 right shell, Catalog # 504-02-68F-R.

The recall was initiated because the device may fall off its post within the 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.

The affected products were distributed worldwide, including in numerous U.S. states such as New York, Texas, California, and Florida. Specific lot numbers are listed in the official recall documentation. Healthcare providers and patients should check their inventory or medical records for these specific catalog and lot numbers and contact Howmedica Osteonics Corp. for further instructions.

The recalled product

Product
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 right, Sterile, Catalog # 504-02-68F-R, UDI (01)07613327012514(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 DD6E5N
  • 3314LE
  • EA67YJ
  • TA05PD
  • MJ71XA
  • VH242D
  • HR43JY
  • 5E8XPW
  • KR4YH2
  • XW7T57
  • W92MH8
  • DY1N6E
  • 4D8EEY
  • 6M7D2N
  • 1T81T1
  • V45AA1
  • YL2DP4
  • H017J0
  • 850EJX
  • DA1ATY

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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Same hazard · packaging defect

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