Z-0868-2007

Profemur R, Revision Hip system, Proximal Body (part), STD 4, REF: PPW38354, Cementless, Titanium Plasma...

Name: Z-0868-2007 Profemur R, Revision Hip system, Proximal Body (part), STD 4, REF: PPW38354, Cementless, Titanium Plasma...
Creator: Wright Medical Technology Inc
Published: 2007-03-27
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2007-03-27 / Terminated

FDA source

Wright Medical Technology Inc began a recall of Profemur R, Revision Hip system, Proximal Body (part), STD 4, REF: PPW38354, Cementless, Titanium Plasma Spray Coated, Sterile, Rx only. Hip implant on 2007-03-27. The reason FDA records is "The titanium plasma coating was found to have missing fragments". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0868-2007
Status: Terminated
Initiated: 2007-03-27
Posted: 2007-06-07
Terminated: 2008-06-30
Recalling firm: Wright Medical Technology Inc
Product: Profemur R, Revision Hip system, Proximal Body (part), STD 4, REF: PPW38354, Cementless, Titanium Plasma Spray Coated, Sterile, Rx only. Hip implant.
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: The titanium plasma coating was found to have missing fragments.
FDA root cause: Other
Action: The firm sent out recall notices to implanting surgeons by letter dated 03/27/2007 (via FedEx) to notify the surgeons of the issue. The hospitals and distributors were also notified of the issue and given instructions for return of the product.
Quantity in commerce: 4 units
Distribution: Nationwide, Puerto Rico, & Japan
Product codes and lots: Lot No. W09350601

Product code LZO

K003016Class IIPro-Femur RWrightmedicaltechnologyinc / cleared 2000-12-13

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)