Z-1715-2009

CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3604, O.D. Size: 36mm, Neck Length: -3.5mm, Taper: SLT...

Name: Z-1715-2009 CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3604, O.D. Size: 36mm, Neck Length: -3.5mm, Taper: SLT...
Creator: Wright Medical Technology Inc
Published: 2009-05-14
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2009-05-14 / Terminated / root cause: packaging

FDA source

Wright Medical Technology Inc began a recall of CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3604, O.D. Size: 36mm, Neck Length: -3.5mm, Taper: SLT, Sterile R, 1 each, Rx only, Wright Medical... on 2009-05-14. The reason FDA records is "Incorrect packaging, swapped sizes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1715-2009
Status: Terminated
Initiated: 2009-05-14
Posted: 2015-06-25
Terminated: 2009-12-09
Recalling firm: Wright Medical Technology Inc
Product: CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3604, O.D. Size: 36mm, Neck Length: -3.5mm, Taper: SLT, Sterile R, 1 each, Rx only, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002. The CONSERVE Total Femoral Head is indicated for use in total hip arthroplasty for reduction of relief of pain and/or improved hip function in skeletally mature patients.
Product code: JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Reason for recall: Incorrect packaging, swapped sizes
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Wright Medical Technology, Inc. notified hospitals, surgeons and their distributors of the recall situation via an "Urgent: Medical Device Voluntary Recall" notice dated May 14, 2009 explaining the problem, the hazard involved and requesting confirmation that the product was removed from their inventory. The letter included a "Fax Back" response page to ensure the receipt of the notice. For further questions, contact Wright Medical Technologies, Inc. at 1-800-874-5630.
Quantity in commerce: 14 units
Distribution: Worldwide Distribution -- Including states of NC, TN, IA, IN, MD, WI, WV, OK, WA, PA, TN, TX, FL and CA and country of Canada.
Product codes and lots: Lot Number: 029798201.

Product code JDL

K051348Class IIIConserve Total Femoral HeadWrightmedicaltechnologyinc / cleared 2005-08-19

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)