Home › BLUSTONE SYNERGY, LLC › Blustone Synergy Cervical Inserter
Blustone Synergy Cervical Inserter
BLUSTONE SYNERGY, LLC · Model 9000-CI01 · UDI-DI 00810482030651
FZX
Prescription
10
510(k) clearances
8,555
Adverse events (4 deaths)
29
Recalls
526
Facilities
Description
The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899. The cervical implant inserter is designed to allow for disassembly during cleaning and sterilization.Instructions regarding disassembly of the inserter instrument are provided in the product insert.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-11-30 | Waldemar Link GmbH & Co. KG (Mfg Site) | Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resec |
| 2022-10-10 | Hologic, Inc | IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set |
| 2019-08-21 | Zimmer Biomet, Inc. | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. |
| 2019-08-21 | Zimmer Biomet, Inc. | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. |
| 2019-08-21 | Zimmer Biomet, Inc. | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. |
| 2018-03-26 | Zimmer Biomet, Inc. | Potential failure of sterile packaging seal. |
| 2017-08-07 | Synthes, Inc. | May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect to the plate intraoperatively, surgical delay could occur. If the pilot hole is dr |
| 2017-04-25 | Cook Inc. | reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products |
| 2016-08-09 | Zimmer Biomet, Inc. | Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as the new revision tissue sleeve will not fit into the old revision targ |
| 2016-06-07 | Synthes (USA) Products LLC | DePuy Synthes is initiating a voluntary medical device recall due to Blade/Screw Guide Sleeves (Part # 03.037.017) may have been manufactured with a slightly larger than specified |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.