Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants
FDA Recall Z-0906-2015 · Posted 2015-01-05
Advertisement
Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2014-10-09
Date Terminated2016-06-08
Product Quantity96
Reason for Recall
Mislabeled
Firm Action
The firm, Exactech, sent an "Urgent Field Safety Notice" letter dated September 30, 2014 to its Consignees/customers by electronic mail on October 9, 2014. The letter described the product, problem and actions to be taken. The customers were instructed to: immediately cease distribution or use of the products; extend information to your accounts that may have this product in their possession; verify whether you have any of the subject femoral components from the specified serial number ranges; complete and return the attached inventory RESPONSE FORM via fax to: 011 61 2 9638 0778 within 48 hrs of receipt of the notice, and contact your Exactech representative to confirm quantities at your location and arrangements for product return and inventory restocking.
If you have any questions, contact Manager, Regulatory Affairs at 352-377-1140.
Root Cause
Labeling mix-ups
Distribution Pattern
International Distribution only to countries of: Argentina, Austria, Australia, China, Cyprus, France, Greece, India, Japan, Lebanon, The Netherlands, Spain and Tunisia.
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.
Advertisement