Z-1696-2009

Exogen Express Bone Healing System, SAFHS, Part Numbers 71034200 and 71034140, Rx only, Smith & Nephew, 1450...

Name: Z-1696-2009 Exogen Express Bone Healing System, SAFHS, Part Numbers 71034200 and 71034140, Rx only, Smith & Nephew, 1450...
Creator: Smith & Nephew Inc
Published: 2009-06-05
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2009-06-05 / Terminated

FDA source

Smith & Nephew Inc began a recall of Exogen Express Bone Healing System, SAFHS, Part Numbers 71034200 and 71034140, Rx only, Smith & Nephew, 1450 Brooks Road, Memphis TX 38116. These are... on 2009-06-05. The reason FDA records is "Problems with transducer may result in a reduced ultrasound output". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1696-2009
Status: Terminated
Initiated: 2009-06-05
Posted: 2009-08-04
Terminated: 2010-11-18
Recalling firm: Smith & Nephew, Inc.
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.
Product code: LPQ Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
Reason for recall: Problems with transducer may result in a reduced ultrasound output.
FDA root cause: Other
Action: 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.
Quantity in commerce: 891 units
Distribution: Worldwide Distribution -- US, Switzerland, Canada, Malaysia, Japan, and UK.
Product codes and lots: 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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Product code LPQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)