Recall Z-1744-2015 ยท KIH Dispenser, Cement
BIOMET FRANCE S.A.R.L.
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.
| Date | Jun 10, 2015 (initiated May 14, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| 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 di |
| Quantity | 3 |
| Distribution | Nationwide distribution to MD only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.