The Optigun Ratchet is a hand-held cement gun for use with Optivac — Class II medical device recall Z-1744-2015
Terminated recall by BIOMET FRANCE S.A.R.L., reported 2015-06-17, distributed nationwide. The pin which maintains the knob button, may disconnect and become lost. This may result in a delay of surgery
| Recall number | Z-1744-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BIOMET FRANCE S.A.R.L., Valence Cedex 9, N/A, France |
| Recall initiated | 2015-05-14 |
| Classified | 2015-06-10 |
| Reported by FDA | 2015-06-17 |
| Terminated | 2015-10-27 |
| Distributed | Nationwide (US) |
| Quantity | 3 |
| Lot numbers | 0101296012 |
| Model numbers | 419500 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1744-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.