I.CO.S®
NEWDEAL · Model 119552ND · UDI-DI 10381780042976
FZX
Prescription
10
510(k) clearances
8,555
Adverse events (4 deaths)
29
Recalls
526
Facilities
Description
The external protection sleeve is used to protect the soft tissues while drilling the bone for the 6.5mm compression screws. This external protection sleeve shall be used with the drilling guide referenced 119541ND inserted within the internal protecting sleeve referenced 119551ND.
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 |
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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.