Recall of the Gynecare Prolift Pelvic Floor Repair Systems (Outer Product Code: PFRT01) from Ethicon
2007.06.08
Product group Non-active implants
Reference 01381/07
Recall of the products Gynecare Prolift Pelvic Floor Repair Systems (Outer Product Code: PFRT01, lot see annex) from Ethicon Inc. The outer box incorrectly identifies the product as Gynecare Prolift Total Pelvic Floor System, although the boxes actually contain a Gynecare Prolift Anterior Pelvic Floor System (Product Code PFRA01). According to the firm the potential patient risk, e.g. that the customers initiate a total pelvic floor repair when a total device is unavailable, is remote.