6 MM X 65 MM X 150 MM HA COATED HALF PIN SST, REF 71070816… recallZ-1741-2012 · Smith & Nephew Inc · initiated Apr 13, 2012

Why it was recalled

Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.

FDA root cause category: Packaging

What the company is doing

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 [email protected]. 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.

Recall details

Recall number

Z-1741-2012

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Apr 13, 2012

Posted by the FDA

Jun 6, 2012

Recalling firm

Smith & Nephew Inc

Quantity

244 units

Product code

JDW

FDA submissions

K023921

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

Product description

6 MM X 65 MM X 150 MM HA COATED HALF PIN SST, REF 71070816, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.

Other devices under the same FDA submission

5 devices cleared under K023921 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• NA 71070806

  Smith & Nephew, Inc. · PIN, FIXATION, THREADED
  3 reports
• NA 71070823

  Smith & Nephew, Inc. · PIN, FIXATION, THREADED
  2 reports
• NA 71070804

  Smith & Nephew, Inc. · PIN, FIXATION, THREADED
  1 report
• NA 71070805

  Smith & Nephew, Inc. · PIN, FIXATION, THREADED
  1 report
• NA 71070818

  Smith & Nephew, Inc. · PIN, FIXATION, THREADED
  1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 61767).

• Z-1725-2012 · Terminated
  4.5 MM X 10 MM X 150 MM HA COATED HALF PIN SST, REF 71070823, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1726-2012 · Terminated
  4.5 MM X 20 MM X 150 MM HA COATED HALF PIN SST, REF 71070824, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1727-2012 · Terminated
  4.5 MM X 30 MM X 150 MM HA COATED HALF PIN SST, REF 71070825, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1728-2012 · Terminated
  4.5 MM X 40 MM X 150 MM HA COATED HALF PIN SST, REF 71070826, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1729-2012 · Terminated
  4.5 MM X 50 MM X 150 MM HA COATED HALF PIN SST, REF 71070827, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1730-2012 · Terminated
  6 MM X 15 MM X 150 MM HA COATED HALF PIN SST, REF 71070828, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1731-2012 · Terminated
  6 MM X 20 MM X 150 MM HA COATED HALF PIN SST, REF 71070800, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1732-2012 · Terminated
  6 MM X 25 MM X 150 MM HA COATED HALF PIN SST, REF 71070802, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1733-2012 · Terminated
  6 MM X 30 MM X 150 MM HA COATED HALF PIN SST, REF 71070804, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1734-2012 · Terminated
  6 MM X 35 MM X 150 MM HA COATED HALF PIN SST, REF 71070806, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1736-2012 · Terminated
  6 MM X 45 MM X 150 MM HA COATED HALF PIN SST, REF 71070835, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1737-2012 · Terminated
  6 MM X 50 MM X 150 MM HA COATED HALF PIN, 1.6 MM CANNULATED, SST, REF 71070822, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1738-2012 · Terminated
  6 MM X 50 MM X 150 MM HA COATED HALF PIN SST, REF 71070810, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1739-2012 · Terminated
  6 MM X 55 MM X 150 MM HA COATED HALF PIN SST, REF 71070812, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1740-2012 · Terminated
  6 MM X 60 MM X 150 MM HA COATED HALF PIN SST, REF 71070814, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1742-2012 · Terminated
  6 MM X 70 MM X 150 MM HA COATED HALF PIN SST, REF 71070818, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1743-2012 · Terminated
  6 MM X 20 MM X 200 MM HA COATED HALF PIN SST, REF 71070801, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1744-2012 · Terminated
  6 MM X 25 MM X 200 MM HA COATED HALF PIN SST, REF 71070803, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1745-2012 · Terminated
  6 MM X 30 MM X 200 MM HA COATED HALF PIN SST, REF 71070805, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1746-2012 · Terminated
  6 MM X 35 MM X 200 MM HA COATED HALF PIN SST, REF 71070807, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1747-2012 · Terminated
  JET-X(R) BAR 5 MM X 45 MM BAR SHORT HALF PIN TI-6AL-4V, REF 71055451, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1748-2012 · Terminated
  JET-X(R) 6 MM X 20 MM SHORT HALF PIN TI-6AL-4V, REF 71056208, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1749-2012 · Terminated
  JET-X(R) 6 MM X 25 MM SHORT HALF PIN TI-6AL-4V, REF 71056258, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1750-2012 · Terminated
  JET-X(R) 6 MM X 30 MM SHORT HALF PIN TI-6AL-4V, REF 71056308, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1751-2012 · Terminated
  JET-X(R) 6 MM X 35 MM SHORT HALF PIN TI-6AL-4V, REF 71056358, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1752-2012 · Terminated
  JET-X(R) 6 MM X 40 MM SHORT HALF PIN TI-6AL-4V, REF 71056408, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1753-2012 · Terminated
  JET-X(R) 6 MM X 45 MM SHORT HALF PIN TI-6AL-4V, REF 71056458, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1754-2012 · Terminated
  JET-X(R) 6 MM X 50 MM SHORT HALF PIN TI-6AL-4V, REF 71056508, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1755-2012 · Terminated
  JET-X(R) 6 MM X 55 MM SHORT HALF PIN TI-6AL-4V, REF 71056558, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1756-2012 · Terminated
  JET-X(R) 6 MM X 60 MM SHORT HALF PIN TI-6AL-4V, REF 71056608, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.