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Terminated

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.

FDA Recall Z-1715-2009 · Posted None

Recalling FirmWright Medical Technology Inc
Recall StatusTerminated
Product CodeJDL
Date Initiated2009-05-14
Date Terminated2009-12-09
Product Quantity14 units

Reason for Recall

Incorrect packaging, swapped sizes

Firm 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.

Root Cause

Packaging process control

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051348CONSERVE TOTAL FEMORAL HEADWrightmedicaltechnologyinc · 2005-08-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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