Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic

FDA Recall Z-0130-2014 · 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.

K951987GENESIS II TOTAL KNEE SYSTEMSmith & Nephew Richards, Inc. · 1995-08-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑