—#82544

Product

CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3635, 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.

FDA product code: JDL — Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Device class: Class 3
Medical specialty: Orthopedic
510(k) numbers: K051348
Affected lot / code info: Lot Number: 029798202.

Why it was recalled

Incorrect packaging, swapped sizes

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Wright Medical Technology Inc
Address: 5677 Airline Rd, Arlington, Tennessee 38002

Distribution

Distribution pattern: Worldwide Distribution -- Including states of NC, TN, IA, IN, MD, WI, WV, OK, WA, PA, TN, TX, FL and CA and country of Canada.

Timeline

Recall initiated: 2009-05-14
Terminated: 2009-12-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #82544. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.