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Intervertebral Disc Preparation Instruments
ALPHATEC SPINE, INC. · Model 256-15-300-1404 · UDI-DI 00190376381237
HTQ
Prescription
0
510(k) clearances
4,622
Adverse events (2 deaths)
5
Recalls
121
Facilities
Description
LIF, BROACH, MEDIAL, 14MM X 04MM
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-04-23 | Greatbatch Medical | Greatbatch Medical has voluntarily initiated a Recall for the Linear Straight Broach Handle (Rasp Handle) and EZ Clean" Linear Broach Handle. Greatbatch Medical has received report |
| 2011-04-21 | Encore Medical, Lp | Strike plate may dislodge from the broach stem handle during impaction of the device. |
| 2009-04-29 | Zimmer Inc. | The broach handle may fracture at the threaded tip during use, which would result in surgical intervention to retrieve the broach or the trial as the threaded tip fragment prevents |
| 2009-03-13 | Zimmer Inc. | The surface finish inside of the broach is not to specification and the instrument may corrode if cleaned and sterilized according to instructions. |
| 2008-01-25 | Stryker Howmedica Osteonics Corp. | Rejuvenate Broach system was designed in a manner that may result in the potential for a medical calcar fracture. |
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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.