—#108982

Product

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.

FDA product code: JDW — Pin, Fixation, Threaded
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K023921
Affected lot / code info: Lot Numbers: 06CT96765A, 07JT12779A, 08GT21563A, 08GT22163A, 09AT27822A, 09FT33133, 09JT35212, 09KT36490, 09LT37625, 09MT38251, 10BT39225, 10CT40105, 10DT41644, 10FT43808, 10HT45636, 10JT46317, 10KT00277, 10KT46845, 11BT03211, 11CT04322, 11DT05497, 11ET06841, 11FT07889, 11HT09577, 11JT10395, 11KT11399, 11LT12165

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.

Root cause (FDA determination)

Packaging

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew Inc
Address: 1450 E. Brooks Rd, Memphis, Tennessee 38116

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2012-04-13
Posted by FDA: 2012-06-06
Terminated: 2015-09-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108982. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.