The Recall Desk
ModerateFDA (Devices)·Z-2426-2015·Announced 2015-08-26

Stryker Recalls rHead and uHead Implants Due to Packaging Integrity Concerns

Stryker Howmedica Osteonics Corp. is recalling specific rHead, uHead, and other radial implants because their sterile packaging may be compromised by transportation.

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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Stryker Howmedica Osteonics Corp. is recalling rHead, uHead, Sigmoid Notch, Remotion, and Radio Capitellum implants. The recall involves 16,992 units that were distributed worldwide. The specific products affected include various sizes and configurations of the rHead Lateral Stem and related radial implants, identified by specific part numbers and lot numbers listed in the official recall notice.

The reason for the recall is that the packaging integrity, specifically the sterile barrier of the packaging type KIT I, may potentially be compromised by transportation. This defect could affect the sterility of the implants. The source text does not report any illnesses, injuries, or deaths associated with this recall.

Healthcare providers and patients who have received these implants should contact Stryker Howmedica Osteonics Corp. for further instructions. The recall is classified as Class II by the FDA, indicating that the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius.
Manufacturer
Stryker Howmedica Osteonics Corp.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
16,992

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)

  • Part Number: 310-0000 (Lateral Assembly
  • Radial Implant
  • Size 1) Lot #'s 22288301
  • 22890701
  • 23424401
  • 23916901
  • 19058-S2
  • 19452-S2
  • 19661-S2
  • 19662-S2
  • 19712-S2
  • 19736-S2 and 19841-S2
  • Part Number: 310-0001 (Lateral Assembly
  • Size 2) Lot #'s 22629201
  • 22890801
  • 23424501
  • 23917001
  • 19453-S2
  • 19737-S2
  • 19765-S2

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 5 recalled by Stryker 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 5 products in this recall →

Related recalls

Same manufacturer · Stryker Howmedica Osteonics Corp.

See all →

Same hazard · packaging integrity

See all →