ZNN Cephalomedullary Short Nail (2021-05-13)

Starting date:

May 13, 2021

Posting date:

May 20, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-75639

Last updated:
2021-05-20

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  Reason
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  Affected products

Affected Products

ZNN Cephalomedullary Short Nail

Reason

Zimmer Biomet is conductinga medical device recall for two specific lots of ZNN CMN Femoral Nail due to a potentialcomminglebetween CCD angle 130°and 125°. All potentially affected product Is being removed from the market. Biggerand smaller angles of the ZNN Nail could be initially recognized visually by the user and again during the assembly of theLag Screw into the nail under fluoroscopy.

The below two steps in the applicable surgical techniques can potentially assist the user to detect the bigger/smaller CCDangle of the ZNN CMN Nail. As recommended in the applicable surgical techniques, during nail assembly step prior totheinsertion of the nail, confirm also that the lag screw hole in the nail is oriented to guide a lag screw into the femoral head.During Lag Screw Placement step, position the targeting guide so that the trajectory of the lag screw cannula will placethe lag screw in the appropriate position in the femoral head and neck. Pins can be held over the skin in line with the lagscrew cannula to help estimate this position and correct CCD angle.

Affected products