Stryker Humerus End Cap Recalled for Potential Sterility Compromise
Stryker GmbH is recalling specific T2 Humerus End Cap implants because the blister pack seal may be compromised, meaning sterility cannot be assured.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 (sterile implant) where injury has not yet been reported, fitting the 'High' severity criteria for potential contamination without confirmed illness.
Plain-English summary
Stryker GmbH is recalling Stryker End Cap T2 Humerus 6mm, 15mm height implants (Catalog Number 18300015S, Lot Number K037E2D). These single-use medical 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, which means the sterility of the implants cannot be assured. The affected units were distributed worldwide, including in the United States and numerous international markets such as Australia, Canada, and various European countries.
Healthcare providers and consumers should stop using the affected implants immediately. Stryker GmbH is the recalling firm responsible for managing this safety action.
The recalled product
- Product
- Stryker End Cap T2 Humerus ¿6mm, 15mm height Catalog Number: 18300015S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Manufacturer
- Stryker GmbH
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 (1)
- Lot Number: K037E2D
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
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