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Terminated

Depuy TK2 Compression Hip Screw trauma plate, Short Barrel, 135 DEG, 4H-92.6mm, sterile; REF 8315-35-104, DePuy Orthopaedics, Inc., Warsaw, IN 46581

FDA Recall Z-0435-2008 · Posted 2008-01-24

Recalling FirmDepuy Orthopaedics, Inc.
Recall StatusTerminated
Product CodeKTT
Date Initiated2007-10-30
Date Terminated2008-04-21
Product Quantity4

Reason for Recall

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.

Firm Action

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.

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K972629DEPUY AE TK2 HIP SCREW SYSTEMDepuy, Inc. · 1997-10-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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