Z-1340-2016 Class II Terminated
FDA device recall Z-1340-2016 was initiated by Zimmer Manufacturing B.V. on March 17, 2016 and is designated Class II. Reason for recall: The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 … The recall status is terminated (terminated March 14, 2017). Affected quantity: TBD.
Recall Details
- Product Type
- Devices
- Report Date
- April 13, 2016
- Initiation Date
- March 17, 2016
- Termination Date
- March 14, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- TBD
Product Description
Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For use in total knee arthroplasty. REF 42-5114-005-14
Reason for Recall
The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-005-14/ Lot: 62646580.
Distribution Pattern
Distributed in US (AL, AZ, CA, GA, HI, ID, KS, LA, MA, MN, MO, NY, OH, OK, PA, TX, UT, VA, and WI) and foreign countries (Korea, Japan, Germany, Singapore, Austria, Italy, South Africa, and Spain).
Code Information
lot 62646580