Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T
Reported: April 24, 2019 Initiated: March 8, 2019 #Z-1172-2019
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
Details
- Recalling Firm
- Integra LifeSciences Corp.
- Units Affected
- 2029
- Distribution
- 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.
- Location
- Plainsboro, NJ
Frequently Asked Questions
What product was recalled? ▼
Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T. Recalled by Integra LifeSciences Corp.. Units affected: 2029.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2019. Severity: Moderate. Recall number: Z-1172-2019.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11