The Recall Desk
ModerateFDA (Devices)·Z-2098-2020·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 in the inner packaging, resulting in loose 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. The hazard involves a packaging defect (device falling off post, coating debris) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Howmedica Osteonics Corp. is recalling 4,895 units of the Stryker Restoration Anatomic Hemispherical Shell, Size 68 left, Sterile (Catalog # 504-02-68F-L). The recall covers specific lot numbers and is classified as Class II by the FDA.

The recall is being issued 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 affected products were distributed worldwide, including in numerous U.S. states.

Healthcare providers and patients should contact Howmedica Osteonics Corp. for instructions on how to handle the affected devices. The source text does not report any specific illnesses or injuries associated with this defect.

The recalled product

Product
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 left, Sterile, Catalog # 504-02-68F-L, UDI (01)07613327012521(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 YX05L9
  • AL6MM6
  • VX02E2
  • 5Y1H86
  • XY5HP7
  • MA49HV
  • A26E76
  • 4V4APT
  • LD87TH
  • MH1RLL
  • 8R05HH
  • A67K6H
  • Y00YXH
  • PA02HR
  • LE0L4W
  • 494M8R
  • 4T4RAV
  • PW2E41
  • 3T59A5
  • T384A0

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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