—#65556

Product

Depuy TK2 Compression Hip Screw trauma plate, Standard Barrel,135 Degree, 4H-92.6mm, sterile; REF 8315-35-004, DePuy Orthopaedics, Inc., Warsaw, IN 46581

FDA product code: KTT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K972629
Affected lot / code info: Lot DHDB73.

Why it was recalled

Mis-etched/labeled as to barrel length: the lot with the short barrel was etched and labeled as a standard barrel and the lot with the standard barrel was etched and labeled as a short barrel.

Root cause (FDA determination)

Process control

Action the firm took

Consignees were notified via Urgent Information, Recall Notice(letter) dated 10/30/07 to determine whether they have product on hand and to contact their sales representative to return the product. Dear Doctor letters will be issued to implanting physicians as they are identified.

Recalling firm

Firm: Depuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: Nationwide including the states of Florida, Massachusetts, Ohio, Pennsylvania, South Carolina, Tennessee and Virginia.

Timeline

Recall initiated: 2007-10-30
Posted by FDA: 2008-01-24
Terminated: 2008-04-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #65556. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.