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RALLY All In One Cement Gun
TECRES SPA · Model 71271610 · UDI-DI 08031497002330
10
510(k) clearances
456
Adverse events (5 deaths)
5
Recalls
99
Facilities
Description
RALLY ALL IN ONE CEMENT GUN is intended to be used for helping the extrusion (and hence the delivery) of the bone cement prepared with the RALLY ALL IN ONE SYSTEM devices.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-02-28 | Zimmer Biomet, Inc. | Lack of an adequate sterilization validation |
| 2015-08-20 | Orthovita, Inc., dBA Stryker Orthobiologics. | Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration |
| 2015-05-14 | BIOMET FRANCE S.A.R.L. | 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 |
| 2012-01-13 | Stryker Instruments Div. of Stryker Corporation | The firm identified two complaints have been reported indicating that the product inside the package did not match with the label information. The product was labeled as Flat Proxi |
| 2011-03-31 | Orthovita, Inc. | Recalling firm has discovered through internal testing that the Cortoss(TM) Delivery Gun may abrade its packaging material under certain transportation and handling conditions. Th |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.