—#82573

Product

Exogen Express Bone Healing System, SAFHS, Part Numbers 71034200 and 71034140, Rx only, Smith & Nephew, 1450 Brooks Road, Memphis TX 38116. These are distributed internationally only. The device is used for the non-invasive treatment of established nonunions excluding skull and vertebra.

FDA product code: LPQ — Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P900009
Affected lot / code info: Part number 71034200 (system), Serial numbers: 0408017701, 0408017702, 0408017703, 0408017704, 0408017705, 0408017706, 0408017707, 0408017708, 0408017709, 0408017710, 0408017711, 0408017712, 0408017713, 0408017714, 0408017715, 0408017716, 0408017717, 0408017718, 0408017719, 0408017720, 0408017721, 0408017722, 0408017723, 0408017724, 0408017725, 0408017726, 0408017727, 0408017728, 0408017729, 0408017730, 0408017731, 0408017732, 0408017733, 0408017734, 0408017735, 0408017736, 0408017737, 0408017738, 0408017739, 0408017740, 0408017741, 0408017742, 0408017743, 0408017744, 0408017745, 0408017746, 0408017747, 0408017748, 0408017749, 0408017750, 0109000456, 0109000457, 0109000458, 0109000459, 0109000461, 0109000485, 0109000495 and 0109000496 and Exogen Express Part number 71034140 (device only), Serial numbers: 0408017129, 0408017132, 0408017133, 0408017138, 0408017147, 0408017155, 0408017157, 0408017158, 0408017161, 0408017162, 0408017168, 0408017171, 0408017175, 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Why it was recalled

Problems with transducer may result in a reduced ultrasound output.

Root cause (FDA determination)

Other

Action the firm took

All affected Smith & Nephew consignees and distributors were notified of problem and the recall by letters (dated June 5, 2009 and June 8, 2009) via US mail. Patients were directed to return the instruments; physicians were informed that their patients were being contacted; and distributors were requested to return their stock and to notify anyone to whom the product was distributed to also return the product. Direct questions to Smith & Nephew, Inc. by calling at 1-800-836-4080.

Recalling firm

Firm: Smith & Nephew Inc
Address: 1450 E. Brooks Rd, Memphis, Tennessee 38116

Distribution

Distribution pattern: Worldwide Distribution -- US, Switzerland, Canada, Malaysia, Japan, and UK.

Timeline

Recall initiated: 2009-06-05
Posted by FDA: 2009-08-04
Terminated: 2010-11-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #82573. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.