Z-1172-2019 Class II Terminated
FDA device recall Z-1172-2019 was initiated by Integra LifeSciences Corp. on March 8, 2019 and is designated Class II. Reason for recall: The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU The recall status is terminated (terminated May 15, 2020). Affected quantity: 2029.
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2019
- Initiation Date
- March 8, 2019
- Termination Date
- May 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2029
Product Description
Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T
Reason for Recall
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
Distribution Pattern
Distributors in AL, CA, CT, FL, GA, HI, IA, ID, KS, KY, MD, MI, MO, MT, NC, NE, NJ, NM, NY, OH, OK,PA, TX, VA, WA, and WI.
Code Information
183349