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.
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 (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
- 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
See all →- HighStryker Hoffmann II Carbon Connecting Rods Recalled Over Potential Cracking After Sterilization
FDA (Devices) · 2026-08-05
- HighStryker Hoffmann II Connecting Rod Micro May Crack After Cleaning and Sterilization
FDA (Devices) · 2026-08-05
- HighStryker Hoffmann II Carbon Connecting Rods Recalled Over Potential Cracking After Sterilization
FDA (Devices) · 2026-08-05
- HighStryker Hoffmann II Carbon Connecting Rods Recalled Over Potential Cracking After Sterilization
FDA (Devices) · 2026-08-05
- HighStryker Hoffmann II Carbon Connecting Rods Recalled Over Potential Cracking
FDA (Devices) · 2026-08-05
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighStryker T2 K-Wire Recall Due to Potential Pouch Seal Integrity Issues
FDA (Devices) · 2016-03-02
- ModerateStryker T2 Guidewire Recalled Due to Potential Packaging Seal Integrity Issues
FDA (Devices) · 2016-03-02
- ModerateStryker T2 K-Wire Recall Due to Potential Packaging Seal Integrity Issues
FDA (Devices) · 2016-03-02
- ModerateStryker T2 Guidewire Recalled Due to Potential Pouch Seal Integrity Issues
FDA (Devices) · 2016-03-02
- ModerateStryker T2 Guidewire Recalled for Potential Pouch Seal Integrity Issues
FDA (Devices) · 2016-03-02
- ModerateStryker T2 Fixation K-Wire Recall Due to Packaging Seal Integrity Concerns
FDA (Devices) · 2016-03-02