GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic
FDA Recall Z-0131-2014 · Posted 2013-11-01
Recalling FirmSmith & Nephew Inc
Recall StatusTerminated
Product CodeJWH
Date Initiated2013-10-07
Date Terminated2016-08-23
Product Quantity4 units
Reason for Recall
Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.
Firm Action
Smith & Nephew sent an Urgent - Product Recall 1st Notification letter to all affected sales staff via email and FedEx on October 7, 2013. The hospital was notified by sales rep on October 9, 2013 and the notification letter was sent to the hospital via Fed Ex on October 11, 2013. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory, discontinue use, quarantine affected products immediately and return to Smith & Nephew. Customers were asked to complete the attached Inventory Return Certification Form and fax to 901-566-7975.
Root Cause
Process control
Distribution Pattern
USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.