Recall Z-1163-2019— Integra LifeSciences Corp.
Class II · Terminated
Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2019-03-08, terminated 2020-05-15. It names 3 FDA 510(k) clearances: K130533, K090076, K060544. Product: Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T. Reason: 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.
- Recalling firm
- Integra LifeSciences Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-03-08
- Terminated
- 2020-05-15
- Firm location
- Plainsboro, NJ, United States
510(k) clearances named in this recall
3 on FDA's record- K130533 — SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS
- K090076 — SALTO TALARIS TOTAL ANKLE PROSTHESIS
- K060544 — SALTO TALARIS TOTAL ANKLE PROSTHESIS
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.