—#180843

Product

WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.

FDA product code: HSN — Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K051023
Affected lot / code info: Lot code 1619947

Why it was recalled

One lot of INBONE Tibial Trays is missing the plasma coating.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The firm initiated the recall by letter on 04/09/2020. The letter requested the consignee immediately cease use and quarantine the product for return.

Recalling firm

Firm: Wright Medical Technology Inc
Address: 11576 Memphis Arlington Rd, Arlington, Tennessee 38002-9497

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2020-04-09
Terminated: 2020-11-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180843. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.