The Recall Desk
HighFDA (Devices)·Z-2376-2020·Announced 2020-06-24

Stryker End Cap Recall Due to Potential Sterility Compromise

Stryker GmbH is recalling specific End Cap implants because the blister pack seal may be compromised, meaning sterility cannot be assured.

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 involves a risk-of-harm product (sterility compromise in a medical implant) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Stryker GmbH is recalling Stryker End Cap, Standard T2 Humerus 6 mm implants (Catalog Number: 18300003S). The recall involves 109 units from Lot Numbers K020793 and K020794. These single-use devices are intended for the temporary fixation, correction, or stabilization of bones.

The recall was initiated because the seal integrity of the blister pack may be compromised. As a result, the sterility of the devices cannot be assured. The affected products were distributed worldwide, including in the United States and numerous international locations such as Australia, Canada, and several European countries.

Healthcare providers and facilities should stop using the affected lots immediately. Consumers who have had these specific implants placed should contact their healthcare provider for guidance. The recall is classified as Class II by the FDA.

The recalled product

Product
Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Manufacturer
Stryker GmbH
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
109

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 (2)

  • Lot Number: K020793
  • K020794

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 15 recalled by Stryker GmbH 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 15 products in this recall →

Related recalls

Same manufacturer · Stryker GmbH

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Same hazard · sterility compromise

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