FDA Medical Device Recalls (openFDA)
Smith & Nephew Inc: 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
- Recall number
- Z-2197-2010
- 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
- Status
- Terminated
- Initiated
- 2010-06-28
- Posted
- 2010-08-10
- Terminated
- 2012-01-23
- Reason
- Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, compromising sterility.
- 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
- 1 unit
- Distribution
- KY, TX, DC, NC, CA, AZ, GA and OH; 3 International: Australia, Malaysia, and Switzerland
- Lot, serial or model codes
- Lot Number: 10DM13784
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JDQ
- Firm FEI
- 1020279
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28