The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac.
FDA Recall Z-1744-2015 · Posted 2015-06-10
Recalling FirmBIOMET FRANCE S.A.R.L.
Recall StatusTerminated
Product CodeKIH
Date Initiated2015-05-14
Date Terminated2015-10-27
Product Quantity3
Reason for Recall
The pin which maintains the knob button, may disconnect and become lost. This may result in a delay of surgery to obtain a new Optigun and detect/retrieve the pin, and may necessitate revision surgery if the pin falls into the surgical site and is not detected.
Firm Action
BIOMET sent an URGENT ADVISORY NOTICE dated May 14, 2015, to all affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to check the product to identify to determine if the pin is defective, if defective they should return it to Biomet Warsaw, following the directions on the Response Form and confirm receipt of the notice by sending back the response form. Questions related to this notice should be directed to (574) 372- 1570 Monday through Friday 8 a.m. to 5 p.m.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide distribution to MD only
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.