FDA Device recall Z-1744-2015
The Optigun Ratchet is a hand-held cement gun for use with Optivac
- FDA Device
- Class II
- terminated
- Published 2015-06-17
On 2015-06-17 the FDA classified a Class II recall of The Optigun Ratchet is a hand-held cement gun for use with Optivac by Biomet France R L, citing 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 necessi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1744-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-14 |
| Published | 2015-06-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet France R L |
| Distribution | US |
Product
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.
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.
Identifiers
| code_info | Catalog number: 419500 Lot number: 0101296012 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1744-2015%22
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