Stryker End Cap T2 Tibia Recalled Due to Compromised Sterility
Stryker GmbH is recalling specific lots of End Cap T2 Tibia 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 (sterile implant) where sterility cannot be assured, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Stryker GmbH is recalling 186 units of the Stryker End Cap T2 Tibia +10 mm (Catalog Number: 18220010S) due to a potential defect in the packaging. The seal integrity of the blister pack may be compromised, which means the sterility of the implants cannot be assured. These single-use devices are intended for the temporary fixation, correction, or stabilization of bones.
The affected lots are K020795 and K020796. The products were distributed worldwide, including the United States, Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, and the United Kingdom. An update on July 21, 2020, added Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg to the distribution list.
Healthcare providers and patients should check their inventory and records for these specific catalog numbers and lot numbers. If the product is found, it should be removed from use and returned to Stryker GmbH in accordance with their recall instructions.
The recalled product
- Product
- Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Manufacturer
- Stryker GmbH
- Affected units
- 186
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: K020795
- K020796
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 →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12