Z-2197-2010

CERCLAGE WIRE, 0.6 MM DIA. X 175 MM LENGTH, SST, REF 71163006, QTY: (6), STERILE R, CE 008, 2020/07, Smith &...

Name: Z-2197-2010 CERCLAGE WIRE, 0.6 MM DIA. X 175 MM LENGTH, SST, REF 71163006, QTY: (6), STERILE R, CE 008, 2020/07, Smith &...
Creator: Smith & Nephew Inc
Published: 2010-06-28
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2010-06-28 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew Inc began a recall of CERCLAGE WIRE, 0.6 MM DIA. X 175 MM LENGTH, SST, REF 71163006, QTY: (6), STERILE R, CE 008, 2020/07, Smith & Nephew, Inc., Memphis, TN 38116, EC REP: Smith &... on 2010-06-28. The reason FDA records is "Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, compromising sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2197-2010
Status: Terminated
Initiated: 2010-06-28
Posted: 2010-08-10
Terminated: 2012-01-23
Recalling firm: Smith & Nephew, Inc.
Product: CERCLAGE WIRE, 0.6 MM DIA. X 175 MM LENGTH, SST, REF 71163006, QTY: (6), STERILE R, CE 008, 2020/07, Smith & Nephew, Inc., Memphis, TN 38116, EC REP: Smith & Nephew Orthopaedics GmbH, Tuttlingen, Germany Usage: Bone fracture fixation
Product code: JDQ Cerclage, Fixation
Reason for recall: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, compromising sterility.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: All affected Smith & Nephew Sales Representatives were notified of problem and the recall was sent via overnight mail on 01/23/2009. All affected Smith & Nephew International Distributors were notified via email and telephone on 01/23/2009. They were instructed to immediately quarantine the product for return.
Quantity in commerce: 1 unit
Distribution: KY, TX, DC, NC, CA, AZ, GA and OH; 3 International: Australia, Malaysia, and Switzerland
Product codes and lots: Lot Number: 10DM13784

Product code JDQ

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)