Z-0523-2014 Class II Terminated
FDA device recall Z-0523-2014 was initiated by Biomet, Inc. on Nov 26, 2013 and is designated Class II. Reason for recall: Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906760 7mm Medium. The recall status is terminated (terminated Jul 7, 2015). Affected quantity: 21.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 25, 2013
- Initiation Date
- Nov 26, 2013
- Termination Date
- Jul 7, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21
Product Description
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.
Reason for Recall
Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906760 7mm Medium.
Distribution Pattern
Nationwide Distribution including MI, IA, IL, IN, and TN.
Code Information
Lot 055450
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0523-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026