Stryker Humerus End Cap Recall Due to Compromised Sterility
Stryker is recalling specific 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 medical device where sterility cannot be assured, creating a risk of harm (infection) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker GmbH is recalling Stryker 1 End Cap T2 Humerus implants, catalog number 18300005S, lot number K02803B. The recall involves 69 units that were distributed worldwide, including the United States, Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom, Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.
The recall is being issued because the seal integrity of the blister pack may be compromised. As a result, the sterility of the devices cannot be assured. These implants are single-use devices intended for the temporary fixation, correction, or stabilization of bones.
Healthcare providers and patients should stop using the affected devices and contact Stryker for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Stryker 1 End Cap T2 Humerus ¿6mm, 5mm height Catalog Number: 18300005S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Manufacturer
- Stryker GmbH
- Affected units
- 69
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: K02803B
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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