Recall Z-1758-2012
Smith & Nephew Inc · initiated April 13, 2012
Product
JET-X(R) 6 MM X 70 MM SHORT HALF PIN TI-6AL-4V, REF 71056708, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
Codes / lots: Lot Number: 09GM10390
Reason for recall
Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
FDA-determined cause: Packaging
Action taken
Smith & Nephew Sales Representatives and Smith & Nephew International Distributors were notified of the problem with the affected product and the recall via email on April 13, 2012. All affected direct consignees were notified via Fed Ex on April 13, 2012. The Urgent Medical Device Recall letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease use and distribution of the product and quarantine them immediately for return. Customers were instructed to complete the Inventory Return Certification Form included with the letter. Customers should fax or email the form to 901-566-7975 or fieldactions@smith-nephew.com. The affected product should be returned to: Smith & Nephew Attn: Global Field Actions Safety Affairs 1450 Brooks Road Memphis, Tennessee 38116 If the affected product was distributed further customers were instructed to provide a copy of the recall letter to these customers.
Details
- Recall number
- Z-1758-2012
- Initiated
- April 13, 2012
- Posted by FDA
- June 6, 2012
- Terminated
- September 22, 2015
- Product code
- JDW – Pin, Fixation, Threaded
- Quantity
- 91 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey
- Recalling firm
- Smith & Nephew Inc, Memphis, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1708-2012 | 4.8 MM X 1.8 MM DRILL FOR HA COATED HALF PINS, CANNULATED, REF 71070845, QTY: (1)…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1709-2012 | 2.0 MM X 191 MM DRILL, REF 71173802, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1710-2012 | 2.7 MM X 191 MM DRILL, REF 71173804, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1711-2012 | 3.5 MM X 191 MM DRILL, REF 71173806, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1712-2012 | 3.2 MM LONG GRADUATED BRAD POINT DRILL, REF 71751149, QTY: (1), STERILE R, Smith &…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1713-2012 | 3.2 MM LONG GRADUATED BRAD POINT DRILL, REF 71780105, QTY: (1), STERILE R, Smith &…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1714-2012 | 3.2 MM IMHS(R) CP SHORT BRAD POINT DRILL, REF 71687001, QTY: (1), STERILE R, Smith &…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1715-2012 | 2.0 MM DRILL BIT, REF 71173501, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1716-2012 | 2.7 MM DRILL BIT, REF 71173503, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1717-2012 | 3.2 MM TROCAR, REF 71751136, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1718-2012 | 6.5 MM CANELLOUS TAP W/ QUICK CONNECT, REF 71173509, QTY: (1), STERILE R, Smith &…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1719-2012 | PERI-LOC(R) TARGETER 2.7 MM PF PIN 18 MM, SST, REF 71173438, QTY: (1), STERILE R, Smith…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1720-2012 | PERI-LOC(R) TARGETER 2.7 MM PF PIN 40 MM, SST, REF 71173406, QTY: (1), STERILE R, Smith…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1721-2012 | PELVIS PIN, REF 71366302, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1722-2012 | ACETABULAR PIN, REF 71366301, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1723-2012 | SMALL JOYSTICK THREADED PIN, REF 71173396, QTY: (1), STERILE R, Smith & Nephew, Inc.…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1724-2012 | LARGE JOYSTICK THREADED PIN, REF 71173339, QTY: (1), STERILE R, Smith & Nephew, Inc.…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1725-2012 | 4.5 MM X 10 MM X 150 MM HA COATED HALF PIN SST, REF 71070823, QTY: (1), STERILE R, Smith…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1726-2012 | 4.5 MM X 20 MM X 150 MM HA COATED HALF PIN SST, REF 71070824, QTY: (1), STERILE R, Smith…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1727-2012 | 4.5 MM X 30 MM X 150 MM HA COATED HALF PIN SST, REF 71070825, QTY: (1), STERILE R, Smith…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1728-2012 | 4.5 MM X 40 MM X 150 MM HA COATED HALF PIN SST, REF 71070826, QTY: (1), STERILE R, Smith…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1729-2012 | 4.5 MM X 50 MM X 150 MM HA COATED HALF PIN SST, REF 71070827, QTY: (1), STERILE R, Smith…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1730-2012 | 6 MM X 15 MM X 150 MM HA COATED HALF PIN SST, REF 71070828, QTY: (1), STERILE R, Smith &…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1731-2012 | 6 MM X 20 MM X 150 MM HA COATED HALF PIN SST, REF 71070800, QTY: (1), STERILE R, Smith &…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1732-2012 | 6 MM X 25 MM X 150 MM HA COATED HALF PIN SST, REF 71070802, QTY: (1), STERILE R, Smith &…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1733-2012 | 6 MM X 30 MM X 150 MM HA COATED HALF PIN SST, REF 71070804, QTY: (1), STERILE R, Smith &…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1734-2012 | 6 MM X 35 MM X 150 MM HA COATED HALF PIN SST, REF 71070806, QTY: (1), STERILE R, Smith &…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1735-2012 | 6 MM X 40 MM X 150 MM HA COATED HALF PIN SST, REF 71070808, QTY: (1), STERILE R, Smith &…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1736-2012 | 6 MM X 45 MM X 150 MM HA COATED HALF PIN SST, REF 71070835, QTY: (1), STERILE R, Smith &…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |
| Z-1737-2012 | 6 MM X 50 MM X 150 MM HA COATED HALF PIN, 1.6 MM CANNULATED, SST, REF 71070822, QTY:…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | 04/13/2012Terminated |