Device product
outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use Gamma Sterilized, Rx inner incorrect label: CurvTek 7 MM Medium, Single Pack Quantity -3, REF 906760 To pass the CurvTek needle, place the jaws of the instrument utilized to grasp the needle on the sides of the needle and orient and needle parallel to the long axis of the instrument. Position the needle to follow the path of the tunnel created by the cartridges. This aligns the needle with the radius of the transosseous tunnel. Advance the needle while rotating the instrument away from the entry point. Gently feed the needle through the length of the tunnel.
Z-0523-2014
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 66964
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21
- Official record key
device-enforcement:Z-0523-2014
Official wording
Reason: Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906760 7mm Medium.
Code information: Lot 055450
Distribution pattern: Nationwide Distribution including MI, IA, IL, IN, and TN.
Derived failure modes
-
Unknown
Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906760 7mm Medium.