Z-2375-2020 Class II Terminated
FDA device recall Z-2375-2020 was initiated by Stryker GmbH on May 7, 2020 and is designated Class II. Reason for recall: Seal integrity of the blister pack may be compromised and sterility cannot be assured The recall status is terminated (terminated September 21, 2023). Affected quantity: 186 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- June 24, 2020
- Initiation Date
- May 7, 2020
- Termination Date
- September 21, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 186 OUS
Product Description
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.
Reason for Recall
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.
Code Information
Lot Number: K020795, K020796