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.
This recall has been terminated (originally issued May 14, 2009).
- Company
- Wright Medical Technology Inc
- Recall Initiated
- May 14, 2009
- Terminated
- December 9, 2009
- Recall Number
- Z-1716-2009
- Quantity
- 15 units
- Firm Location
- Arlington, TN
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect packaging, swapped sizes
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.
Lot / Code Info
Lot Number: 029798202.
Root Cause
Packaging process control
Action Taken
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.