Z-1526-2016 Class II Terminated
FDA device recall Z-1526-2016 was initiated by Corin USA Limited on January 29, 2016 and is designated Class II. Reason for recall: Potential for abrasion of the sterile barrier pouches of the new packaging system. The recall status is terminated (terminated December 16, 2019). Affected quantity: 629 devices in total.
Recall Details
- Product Type
- Devices
- Report Date
- May 4, 2016
- Initiation Date
- January 29, 2016
- Termination Date
- December 16, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 629 devices in total
Product Description
Trinity Acetabular System Product Usage - Total Hip Replacement.
Reason for Recall
Potential for abrasion of the sterile barrier pouches of the new packaging system.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of CA, FL, ID, TX, OK, OH, MA, and NC and the countries of Australia Belgium, Egypt, Germany, Ghana, Italy, Japan, Poland, South Africa and UK.
Code Information
Non Occluded TPS Shell 048mm Taper SZ2, Lot Code: 323741