Z-0435-2008

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

Name: Z-0435-2008 Depuy TK2 Compression Hip Screw trauma plate, Short Barrel, 135 DEG, 4H-92.6mm, sterile; REF 8315-35-104...
Creator: Depuy Orthopaedics, Inc.
Published: 2007-10-30
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2007-10-30 / Terminated / root cause: manufacturing process

FDA source

Depuy Orthopaedics, Inc. began a recall of 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 on 2007-10-30. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0435-2008
Status: Terminated
Initiated: 2007-10-30
Posted: 2008-01-24
Terminated: 2008-04-21
Recalling firm: Depuy Orthopaedics Inc.
Product: 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
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 4
Distribution: Nationwide including the states of Florida, Massachusetts, Ohio, Pennsylvania, South Carolina, Tennessee and Virginia.
Product codes and lots: Lot DHDB6P.

Product code KTT

K972629Class IIDepuy Ae Tk2 Hip Screw SystemDepuy, Inc. / cleared 1997-10-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)