Recalls / —

—#196311

Product

Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4

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

GTIN 00840420124159, Lot Code: 1725563

Why it was recalled

The tibial tray lock detail is oversized (larger than specification).

Root cause (FDA determination)

Device Design

Action the firm took

Stryker notified consignees on about 09/30/2022, via letter that was hand delivered or sent via email titled, "URGENT: MEDICAL DEVICE RECALL." The letter instructed consignees to check inventory and quarantine any affected product, return the enclosed response form, arrange for the return of affected product and notify all applicable parties of the recall if product was further distributed.

Recalling firm

Firm

Wright Medical Technology, Inc.

Address

1023 Cherry Rd, Memphis, Tennessee 38117-5423

Distribution

Distribution pattern

US Nationwide distribution in the state of New York.

Timeline

Recall initiated

2022-09-30

Posted by FDA

2022-10-27

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #196311. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.